[METRIC]
A-A-51813A
28 August 1992
SUPERSEDING
A-A-0051813 (DM)
30 January 1987
COMMERCIAL ITEM DESCRIPTION
AMIODARONE HYDROCHLORIDE TABLETS
The General Services Administration has authorized the use of this Commercial Item Description.
Salient characteristics:
Shall be Amiodarone Hydrochloride Tablets.
Shall contain 200 mg of Amiodarone Hydrochloride per tablet within the applicable assay limits.
Materials used in the manufacture of the tablets shall be of a pharmaceutical grade.
Each tablet shall be marked/embossed with a product identification code to identify the active ingredient(s), strength, and manufacturer. The materials used in marking/embossing the dosage forms shall be acceptable to the FDA. The actual code used for the product shall be left to the discretion of the supplier.
Workmanship. The tablets shall be free from defects which detract from their appearance or impair its serviceability.
Unit. Bottle (BT). One bottle containing 60 tablets, as specified, constitutes one unit. Bottle shall have a minimum height of 51 mm base to shoulder and shall be supplied with a child-resistant safety closure.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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