PAR STERILE PRODUCTS Affordable Products. Quality You Can Trust. MAY 2017 PRODUCT CATALOG
MDV - Multiple Dose Vial N/A - Not Applicable *Product Requires Refrigeration Adrenalin Injection epinephrine injection, USP 42023-159-25 1 mg/ml 3 ml SUV 1 ml 25 20-25 C (68-77 F) Y Y 10124617 4905352 2070274 611178 and freezing 42023-168-01 1 mg/ml 36 ml MDV 30 ml 1 20-25 C (68-77 F) N Y 10134339 4967956 2409985 109884 and freezing Adrenalin Chloride Solution for topical application epinephrine nasal solution, USP 42023-103-01 1 mg/ml 1 oz. vial 30 ml 1 20-25 C (68-77 F) N Y 10008071 4054433 1474691 829960 and freezing * Aplisol tuberculin purified protein derivative, diluted 42023-104-01 5 TU/0.1 ml 3 ml MDV 1 ml 1 2-8 C (36-46 F) N Y 10025539 4072344 1479328 847343 Do not freeze 42023-104-05 5 TU/0.1 ml 10 ml MDV 5 ml 1 2-8 C (36-46 F) N Y 10025537 4072351 1453042 847350 Do not freeze Argatroban Injection 42023-182-01 250 mg/2.5 ml 5 ml SDV 2.5 ml 1 20-25 C (68-77 F) Y Y 10152268 5099080 3462090 265017 Do not freeze 2
MDV - Multiple Dose Vial N/A - Not Applicable Brevital Sodium Lyophilized Powder for Injection methohexital sodium for injection, USP 42023-105-01 500 mg 50 ml MDV N/A 1 20-25 C (68-77 F) Y Y 10012619 4098612 1888817 878728 42023-106-01 2.5 g 50 ml MDV N/A 1 20-25 C (68-77 F) Y Y 10038452 4066544 1465301 846832 Buprenorphine HCl Injection, 42023-179-05 0.3 mg/ml 3 ml SDV 1 ml 5 20-25 C (68-77 F) Y Y 10153802 5120654 3475027 181099 Protect from prolonged exposure to light Colistimethate for Injection, USP Lyophilized Powder For Injection, USP 42023-131-01 150 mg 10 ml SDV N/A 1 20-25 C (68-77 F) Y Y 10109027 4601522 1449073 702175 colistin base activity 42023-131-06 150 mg 10 ml SDV N/A 6 20-25 C (68-77 F) Y Y 10109028 4601654 1449065 702324 colistin base activity Coly-Mycin M Lyophilized Powder for Injection colistimethate for injection, USP 42023-107-01 150 mg 10 ml SDV N/A 1 20-25 C (68-77 F) Y Y 10011980 4133997 1437698 993006 colistin base activity 42023-107-06 150 mg 10 ml SDV N/A 6 20-25 C (68-77 F) Y Y 10096988 4438016 2155356 543181 colistin base activity 3
MDV - Multiple Dose Vial N/A - Not Applicable **Dantrium IV is a non-returnable product ** Dantrium Intravenous Lyophilized Powder for Injection dantrolene sodium for injection 42023-123-06 20 mg 70 ml SDV N/A 6 20-25 C (68-77 F) Y Y 10012960 4219929 1804137 956995 dantrolene sodium 3000 mg mannitol Avoid prolonged exposure to light Dantrium Capsules dantrolene sodium, capsules 42023-124-01 25 mg N/A 100 Capsules 1 bottle 20-25 C (68-77 F) Y Y 10013047 4238788 1202506 993014 42023-125-01 50 mg N/A 100 Capsules 1 bottle 20-25 C (68-77 F) Y Y 10001438 1376490 1208669 994228 Delestrogen estradiol valerate injection, USP 42023-110-01 10 mg/ml 5 ml MDV 5 ml 1 20-25 C (68-77 F) N Y 10006607 4034492 1488485 826461 42023-111-01 20 mg/ml 5 ml MDV 5 ml 1 20-25 C (68-77 F) N Y 10006609 4034740 1482207 826644 42023-112-01 40 mg/ml 5 ml MDV 5 ml 1 20-25 C (68-77 F) N Y 10006611 4070322 1470897 847129 Dexmedetomidine HCl, Injection 42023-146-25 200 mcg/2 ml 3 ml SDV 2 ml 25 20-25 C (68-77 F) Y Y 10130802 4946752 2057628 884635 4
MDV - Multiple Dose Vial N/A - Not Applicable Ephedrine Sulfate Injection, USP 42023-216-25 50 mg/ml 3 ml SDV 1 ml 25 20-25 C (68-77 F) Y Y 10173725 5326020 3625639 852137 with excursions permitted to 15 C to 30 C (59 F to 86 F).. Ethacrynate Sodium for Injection, USP 42023-157-01 50 mg/vial 50 ml SDV N/A 1 20-25 C (68-77 F) Y Y 10153826 5120910 3475175 181727 Fluphenazine Decanoate Injection, USP 42023-129-01 25 mg/ml 5 ml MDV 5 ml 1 20-25 C (68-77 F) N Y 10141379 5001987 2905982 407015 Ganciclovir Sodium Injection, USP 42023-173-25 500 mg/vial 10 ml SDV N/A 25 20-25 C (68-77 F) Y Y 10174960 5348818 3645207 908392, Protect from moisture 5
MDV - Multiple Dose Vial N/A - Not Applicable Ketalar ketamine hydrochloride injection, USP 42023-113-10 10 mg/ml 20 ml MDV 20 ml 10 20-25 C (68-77 F) N Y 10008474 4063418 1472166 845693 42023-114-10 50 mg/ml 10 ml MDV 10 ml 10 20-25 C (68-77 F) N Y 10055500 4132171 1383405 946475 42023-115-10 100 mg/ml 5 ml MDV 5 ml 10 20-25 C (68-77 F) N Y 10008477 4065223 1457837 846493 Levothyroxine Sodium for Injection 42023-201-01 100 mcg/vial 6.5 ml N/A 1 20-25 C (68-77 F) Y Y 10167125 5272224 3568037 781096 42023-202-01 200 mcg/vial 10 ml N/A 1 20-25 C (68-77 F) Y Y 10167121 5272307 3568045 781112 42023-203-01 500 mcg/vial 10 ml N/A 1 20-25 C (68-77 F) Y Y 10167120 5272315 3568052 781211 Melphalan Hydrochloride for Injection NDC Description Strength Vial Size Fill Volume PF LF Pack Size Storage ABC Cardinal McKesson M&D Melphalan Hydrochloride 50 mg/vial 15 ml SUV N/A 20-25 C (68-77 F) for Injection 42023-149-01 Y Y 1 10168692 5283254 3582996 812750 Diluent 10 ml/vial 10 ml SUV 10 ml 6
MDV - Multiple Dose Vial N/A - Not Applicable Meropenem for Injection, USP 42023-191-10 500 mg/vial 20 ml SDV N/A 10 20-25 C (68-77 F) Y Y 10174932 5349238 3645157 910000 42023-192-10 1 g/vial 30 ml SDV N/A 10 20-25 C (68-77 F) Y Y 10174933 5349246 3645165 909937 Mycophenolate Mofetil for Injection, USP 42023-172-04 500 mg/vial 20 ml SDV N/A 4 20-25 C (68-77 F) Y Y 10170945 5306477 3604998 864975 Neostigmine Methylsulfate Injection, USP 42023-188-10 0.5 mg/ml 10 ml MDV 10 ml 10 20-25 C (68-77 F) N Y 10177622 5363114 3664232 967240 Protect from Light 42023-189-10 1 mg/ml 10 ml MDV 10 ml 10 20-25 C (68-77 F) N Y 10177621 5363122 3664273 967281 Protect from Light 7
MDV - Multiple Dose Vial N/A - Not Applicable *Product Requires Refrigeration Pitocin oxytocin injection, USP, synthetic 42023-116-25 10 units/ml 3 ml SDV 1 ml 25 20-25 C (68-77 F) N Y 10024924 4047197 1804798 829564 42023-116-01 10 units/ml 10 ml MDV 10 ml 1 20-25 C (68-77 F) N Y 10027650 4056230 1451517 845560 42023-116-02 10 units/ml 10 ml MDV 10 ml 25 20-25 C (68-77 F) N Y 10098671 4492963 2428480 625871 Tigan trimethobenzamide hydrochloride, injectable 42023-118-01 100 mg/ml 20 ml MDV 20 ml 1 20-25 C (68-77 F) N Y 10011143 4098679 1889682 917716 42023-119-25 100 mg/ml 3 ml SDV 2 ml 25 20-25 C (68-77 F) Y Y 10047935 4086913 1427913 918912 * Triostat liothyronine sodium injection (T 3 ) 42023-120-01 10 mcg/ml 2 ml SUV 1 ml 1 2-8 C (36-46 F) Y Y 10117406 4877007 2021806 265439 42023-120-06 10 mcg/ml 2 ml SUV 1 ml 6 2-8 C (36-46 F) Y Y 10007844 4090486 1464262 875518 * Vasostrict Vasopressin Injection, USP 42023-164-25 20 units/ml 3 ml SDV 1 ml 25 2-8 C (36-46 F) Y Y 10145143 5033428 3424330 913442 Do not freeze 42023-190-01 200 units/10ml 10 ml MDV 10 ml 1 2-8 C (36-46 F) N Y 10173721 5324769 3626108 884478 (20 units/ml) Do not freeze Unopened vials may be held up to 12 months upon removal from refrigeration to room temperature storage conditions (20 C to 25 C [68 F to 77 F], USP Controlled ), anytime within the labeled shelf life. 8
RETURN GOODS POLICY This Return Goods Policy (the Policy ) of Par Sterile Products, Inc. applies to Par s sterile injectable pharmaceutical products (sometimes collectively referred to herein as Product ) distributed by Par Sterile Products Inc., or JHP Pharmaceuticals, Inc. (collectively referred to herein as PSP ). This policy does not apply to brand or generic Products distributed by Par Pharmaceutical Inc. or Anchen Pharmaceuticals, Inc. PSP will only accept the return of Product for consideration of credit or refund, if applicable, under the following conditions and limitations: This Policy is in effect as of November 1, 2014 and supersedes all previous policies. Return Authorization Designee Inmar Inc. ( MedTurn ) is the approved return goods agent for PSP. Customers returning eligible return goods to Inmar do not incur any processing fees or service charges. Inmar will accept PSP return goods shipments from other third party return goods processors provided such processors comply with all requirements of this Policy. PSP reserves the right to deny credit for returns sent to reverse distribution vendors other than Inmar. Return Instructions All Returns must be sent directly to Inmar. Use one of the following options to initiate each return. 1. Access the Inmar website at https://clsnetlink.com (customers are required to upload a debit memo copy in PDF format). 2. E-mail debit memo to rarequest@inmar.com. Be sure to include NDC#, lot# and expiration dates assigned to each item. 3. Fax debit memo to Inmar at 817-868-5343 Questions about the returns process may be directed to Inmar s customer service at (800) 967-5952 Monday through Friday between the hours of 7:00am and 5:00pm central time. Request for return or return Product does not constitute PSP s acceptance for credit. The package size, lot number and lot expiration date will be obtained and verified after receipt of Product at Inmar. Product should be shipped pre-paid to: Inmar South Dock 4332 Empire Road Fort Worth, TX 76155 Returns of Product must include a packing list containing the following information: Name and address of facility returning Product Phone number DEA number List of Product including quantity being returned, lot number and expiration date of each An Inmar box label must accompany all returns for proper credit A detailed debit memo indicating total number of units being returned must be included with all returns for reimbursement. NDC and lot numbers on customer debit memo must match that of the PSP NDC and lot number of the full unit of measure marketed by PSP (must use parent NDC and lot, not child or sub NDC or lot, if applicable). All eligible Product shipped to Inmar must be shipped in a safe, secure and reliable manner, and in compliance with all applicable federal, state and local laws. PSP is not responsible for shipments lost and/or damaged in transit. It is suggested that the customer returning Product insure all shipments. Dantrium Intravenous Lyophilized Powder for Injection 20mg 70mL SDV 6 s ( Dantrium IV ) is not returnable for credit but is returnable for destruction. Terms of Return Policy PSP will only consider for return Product that is purchased directly from PSP or through an agent authorized by PSP to sell PSP Product. Controlled Substances Controlled substances must be returned to Inmar in accordance with Federal and State regulations governing the transfer of these substances. Submission of DEA Form 41s, in lieu of returning Product to Inmar, will not qualify for credit. Customer shall contact Inmar at (800)967-5952 as described above and Inmar shall provide designated label and DEA 222 form. Prior to the return of any Schedule II narcotic, a DEA Form 222 must be issued by Inmar and the completed form must accompany the return goods shipment. Schedule II Product must be returned separate and apart from Schedule III, IV, and V Product and non-controlled Product. Schedule II return goods shipments must be shipped in an unmarked container via UPS, DHL or FedEx. Valuation of Returns For direct customers, a credit will be issued based upon the lower of the current Wholesaler Acquisition Cost (WAC) at the time the returned merchandise is received by Inmar OR the lowest invoice price paid. For returns of Product purchased indirectly and returned through a wholesaler or distributor, a credit will be issued at the lower of the current or most recently available net contract price at the time the returned merchandise is received by Inmar. If none exists, or cannot reasonably be determined, then credit will be based on 50% of the current WAC price. Returnable Items For the purpose of this Policy, returns will be accepted for credit only if such returned Product is in accordance with the requirements set forth below: Unopened, sealed containers (i.e. unopened vials, bottles, etc.) returned in the original labeled package; Valid Lot number and expiration date are legible; Product returned no more than six (6) months prior to the expiration date; Product returned no more than six (6) months after the expiration date; Recalled Product returned separately from short dated or expired Product and returned through PSP s approved Recall Processing Service. PSP will only accept returns from customers who have purchased Product directly from PSP. Returns from indirect customers will be accepted only if the debit memo provides for remittance through a direct customer of PSP. Returns are to be made to the wholesaler/distributor from which the Product was purchased. Check reimbursement will not be offered in lieu of credit. Non-Returnable Items Non-Returnable Items include the following: Partially or fully opened containers (no partial credits will be issued except as required by state or local laws); Product more than six (6) months prior to expiration date; Product more than six (6) months after expiration date; Product requiring refrigeration or product that is required to be stored and maintained under temperature controlled conditions. Product where either the lot number, the NDC number, and/or expiration date is missing, covered, removed, or unreadable; Professional samples, professional packages or free goods; 9
Open, unsealed packages or empty containers; Product damaged by water, fire, smoke, or due to improper storage conditions or other insurable events Product involved in salvage, bankruptcy or insolvency proceedings; Product sold, purchased or distributed in violation of federal, state or local law; Packages from which labels have been defaced, covered, removed, or unreadable; or in leaking containers; Private label, repackaged Product, or any Product manufactured to customer specs; Product that is otherwise adulterated, misbranded, or counterfeit, as determined by PSP, in its sole discretion; Overstock items; Product that has been donated; Product sold expressly on a non-returnable basis; Non approved returns; Product not distributed by PSP; Product destroyed by any wholesaler or third party processor for customer or wholesaler not authorized by PSP; Product destroyed in the field, regardless of whether proof of destruction is supplied; Product returned by anyone other than the original purchaser. PSP reserves the right to request proof of purchase prior to authorizing any returns; Product returned to PSP s distribution center without prior approval; Returns to PSP s distribution center made after thirty (30) days from date of approval; Product not purchased directly from PSP or obtained other than through a source of normal distribution channels and/or purchased from a source other than an approved distributor of PSP. Product that has been purchased from sources outside of the United States, Puerto Rico or US territories; Product shall be ineligible for return when the intent of the customer is to temporarily reduce inventory. Credit may be reduced or refused when inadequate inventory controls cause excessive Product returns. Dantrium Intravenous Lyophilized Powder for Injection 20mg 70mL SDV 6 s ( Dantrium IV ) is not returnable for credit but is returnable for destruction. Ineligible Product should not be sent back to PSP. Product not eligible for return and sent to Inmar will not be returned to sender and will not be eligible for credit. PSP reserves the right to destroy any Product that is not eligible for credit without payment or liability. PSP reserves the right to deduct costs incurred for the processing/ destruction of ineligible returned Product from the total credit of the return. Delivery and Shipping Exceptions For Product returns due to shipping error or Product damaged in shipment, contact PSP s Return Goods Administration at 800-828-9393, option #5, and then press #3 or visit our website, http://customer.parpharm.com for more information. When PSP Product is found to be missing from a delivered shipment an immediate notification must be initiated to PSP by calling 800-828-9393, option #5, and then press #3. The loss of DEA regulated Product (Control Drug Substances) require a notification to Federal Authorities within 24 hours of a finding which must be initiated by PSP should a loss be reported by our customer. Product shipped directly by PSP that is damaged in transit, subject to F.O.B terms; Product shipped in error by PSP, and/or concealed damage at time of shipment, must be reported to PSP s Return Goods 10 Administration within five (5) business days from date of receipt. Controlled Substance Product shipped directly by PSP that is damaged in transit, subject to F.O.B. terms; Product shipped in error by PSP, and/or concealed damage at time of shipment must be reported to PSP s Return Goods Administration within 24 hours of receipt. Subject to approval by PSP, an even exchange or credit will be allowed for loss or damage evident at delivery time if noted on the carriers delivery receipt and reported to PSP within five (5) days. Concealed loss or damage must be inspected by the carrier within fifteen (15) days after delivery and Carrier s inspection report must be forwarded to PSP. Product damaged at customer s warehouse or store level will not be credited or replaced. Additional Terms PSP will issue credit for returns in compliance with all federal and state requirements Unauthorized deductions for returned merchandise are not permitted without prior approval. Debit memo amounts are pro-forma estimates only and are not considered as valid and therefore should not be deducted from payments to PSP until such time as payment of amount due, if any, is determined by PSP and credit is issued. Returned quantities will be audited by PSP s authorized agent and final credit will be based on PSP s authorized agent s count. PSP reserves the sole right to determine whether items qualify for return or credit. PSP s determination of the physical count of the returned Product will be final. With the exception of recalled Product, or where due to PSP s error, PSP will not pay for, nor reimburse wholesalers or any customer for, any return goods transportation costs, handling fees, or processing fees incurred on the part of the wholesaler/ distributor, distributor s return goods processor or customer. Direct customers are not permitted to deduct from any payment any such return transportation costs, handling fees or processing fees. PSP will not reimburse customers for destruction charges for Product destroyed by any party other than PSP s authorized agent. Any and all credits provided under this Policy are only valid if redeemed within one year of issuance. Credit will be issued to direct purchasing customers within sixty (60) days after receipt of an approved return. Customers may not take deductions for returns prior to the issuance of a credit memo. All claims relating to Product returns must be made in writing to PSP within twelve (12) months of date of return. Any claim made outside of this notice period will not be reviewed or considered. When indirect returns are processed by a third Party, proof of destruction must be provided in order for credit to be issued. PSP reserves the right to verify all Product returns to make certain that they conform to this Policy. PSP reserves the right to modify and make changes to this Policy without notice. Pre-Authorized in-date returns due to overstock are subject to a 20% handling and restocking fee. Prior written approval by PSP is required and chain of custody documented and approved by PSP.
Drug Safety / Medical Information To report adverse events or product complaints, please call: Phone: 800-828-9393 Option 3 EFax: 201-829-9222 Email: drugsafety@parpharm.com For medical information inquiries, please call: Phone: 800-828-9393 Option 2 EFax: 201-829-9222 Email: druginfo@parpharm.com For customer service inquiries, please call: 800-828-9393, option 5, option 2 www.parsterileproducts.com 2017 PSPM03 0417