Estradiol tablet

Ingredients and appearance - Product information

Estradiol tablet- Estradiol

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 33261-667
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Estradiol ( UNII: 4TI98Z838E)( Estradiol - UNII: 4TI98Z838E ) 1 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Starch, corn ( UNII: O8232NY3SJ)
Calcium phosphate, dibasic, anhydrous ( UNII: L11K75P92J)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
D&c red no. 27 ( UNII: 2LRS185U6K)
Aluminum oxide ( UNII: LMI26O6933)

Product Characteristics

Color PURPLE (light purple) Imprint Code 886;1;b
Score 2 Shape OVAL
Size 9 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040197 USA

Estradiol tablet- Estradiol

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 33261-714
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Estradiol ( UNII: 4TI98Z838E)( Estradiol - UNII: 4TI98Z838E ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Starch, corn ( UNII: O8232NY3SJ)
Calcium phosphate, dibasic, anhydrous ( UNII: L11K75P92J)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c yellow no. 5 ( UNII: I753WB2F1M)
Aluminum oxide ( UNII: LMI26O6933)

Product Characteristics

Color GREEN Imprint Code 887;2;b
Score 2 Shape OVAL
Size 9 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040197 USA

Labeler - Aidarex Pharmaceuticals LLC( 801503249)

adapted from JAMA, 2002; 288:321-333

a subset of the events was combined in a global index, defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, or death due to other causes

nominal confidence intervals unadjusted for multiple looks and multiple comparisons
includes metastatic and non-metastatic breast cancer with the exception of in situ breast cancer

not included in Global Index