A-A-51567A
3 September 1987
COMMERCIAL ITEM DESCRIPTION
NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP (Triphasic)
The General Services Administration has authorized the use of this Commercial Item Description.
Salient characteristics:
Shall be Norethindrone and Ethinyl Estradiol Tablets, USP.
Shall be in accordance with the requirements of the USP.
All ingredients shall be of pharmaceutical grade.
For Type I, tablets within the cycle shall contain Norethindrone 0.5 mg and Ethinyl Estradiol 0.035 mg; Norethindrone 0.75 mg and Ethinyl Estradiol 0.035 mg; Norethindrone 1.0 mg and Ethinyl Estradiol 0.035 mg; and inert ingredients as described below. Cycle shall consist of seven tablets containing 0.5 mg Norethindrone and 0.035 mg Ethinyl Estradiol, followed by seven tablets containing 0.75 mg Norethindrone and 0.035 mg Ethinyl Estradiol, followed by seven tablets containing 1.0 mg Norethindrone and 0.035 mg Ethinyl Estradiol, followed by seven tablets containing inert ingredients. Twenty eight tablets, as specified above, shall constitute one cycle.
For Type II, Tablets within the cycle shall contain Norethindrone 0.5 mg and Ethinyl Estradiol 0.035 mg; Norethindrone 1.0 mg and Ethinyl Estradiol 0.035 mg; and inert ingredients as described below. Cycle shall consist of seven tablets containing 0.5 mg Norethindrone and 0.035 mg Ethinyl Estradiol, followed by nine tablets containing 1.0 mg Norethindrone and 0.035 mg Ethinyl Estradiol, followed by five tablets containing 0.5 mg Norethindrone and 0.035 mg Ethinyl Estradiol, followed by seven tablets containing inert ingredients. Twenty eight tablets as specified above shall constitute one cycle.
Workmanship. Tablets shall be free from defects which detract from their appearance or impair its serviceability.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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