October 28, 1981
COMMERCIAL ITEM DESCRIPTION
ISOSORBIDE DINITRATE TABLETS, MODIFIED
The General Services Administration has authorized the use of this Commercial Item Description.
This drug is a smooth muscle relaxant that may be used in the treatment of chronic angina pectoris.
SALIENT CHARACTERISTICS: This Commercial Item Description applies to various oral tablet strengths, packaged in various quantities according to customary commercial practice, including unit of use and unit dose. The tablets shall meet the USP requirements of Isosorbide Dinitrate Tablets except the tabletsí disintegration shall not exceed 30 minutes when determined by the USP method for uncoated tablets, using Simulated Gastric Fluid TS as the immersion fluid. Expiration dating shall be not less than 18 months remaining at the time of delivery to the Government, and may range up to 60 months, as deemed appropriate by the contracting officer.
CONTRACTOR CERTIFICATION. The contractor shall certify that the product offered meets the salient characteristics of this description, and conforms to the producerís own drawings, specifications, standards and quality assurance practices, and is the same as the product sold in the commercial marketplace. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
Federal Food, Drug and Cosmetic Act- If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor ;hall comply, and be responsible for compliance by its subcontractors/ suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder, In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, and regulations.
Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580 to the maximum extent practical.
PRESERVATION, PACKAGING, PACKING, LABELING, AND MARKING: Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling etc., involving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carrierís rules and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order.
For Information Only- The following products, as of the date of this document, are purported by the following companies to meet the salient characteristics of the item described herein: Isordil Oral Titradose Tablets, 10 mg, NDC 0082-4153-02, Ives Laboratories, Inc.; Sorbitrate Oral Tablets, 10 mg., NDC 0038-0780-50, Stuart Pharmaceuticals Division.
Military Coordinating Activity:
VA-OSS VAMKC (904E)
VA-OSS VAC0 (93C)
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