Source: FDA, National Drug Code (US) Revision Year: 2016
ESTRACE (estradiol tablets USP) for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17ß-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17ß-diol. The structural formula is:
C18H24O2 M.W. 272.38
Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake.
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ESTRACE (estradiol tablets USP) are available as: 0.5 mg: White to off-white, oval, flat-faced, beveled-edge, scored tablet. Debossed with 720/½ on the scored side and WC on the other side. Available in bottles of: 100 Tablets NDC 0430-0720-24 1 mg: Light purple, oval, flat-faced, beveled-edge, scored tablet. Debossed with 721/1 on the scored side and WC on the other side. Available in bottles of: 100 Tablets NDC 0430-0721-24 2 mg: Green, oval, flat-faced, beveled-edge, scored tablet. Debossed with 722/2 on the scored side and WC on the other side. Available in bottles of: 100 Tablets NDC 0430-0722-24 Mfd by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 Marketed by: Allergan USA, Inc., Irvine, CA 92612 |
| Drug | Countries | |
|---|---|---|
| ESTRACE | Canada, United States |
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