Prescription Drug Information: Esterified Estrogens and Methyltestosterone (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.625mg 1.25mg Label
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1.25mg 2.5mg Label
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ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE
esterified estrogens and methyltestosterone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-077
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, ESTERIFIED (ESTROGENS, ESTERIFIED) ESTROGENS, ESTERIFIED 0.625 mg
METHYLTESTOSTERONE (METHYLTESTOSTERONE) METHYLTESTOSTERONE 1.25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM BICARBONATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue (light blue) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code IP;77
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-077-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/22/2010
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE
esterified estrogens and methyltestosterone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-078
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, ESTERIFIED (ESTROGENS, ESTERIFIED) ESTROGENS, ESTERIFIED 1.25 mg
METHYLTESTOSTERONE (METHYLTESTOSTERONE) METHYLTESTOSTERONE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM BICARBONATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color green Score no score
Shape OVAL Size 14mm
Flavor Imprint Code IP;78
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-078-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/22/2010
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)

Revised: 11/2022 Amneal Pharmaceuticals of New York LLC

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