Estradiol (Page 10 of 10)

0.075 mg/day carton
(click image for full-size original)

0.1 mg/day pouch
(click image for full-size original)

0.1 mg/day carton
(click image for full-size original)
ESTRADIOL estradiol patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1629
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.025 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)
OLEYL ALCOHOL
POVIDONE
DIPROPYLENE GLYCOL
Product Characteristics
Color Score
Shape ROUND Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1629-7 8 POUCH in 1 CARTON contains a POUCH (69238-1629-1)
1 NDC:69238-1629-1 1 d in 1 POUCH This package is contained within the CARTON (69238-1629-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211293 02/04/2019
ESTRADIOL estradiol patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1630
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.0375 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)
OLEYL ALCOHOL
POVIDONE
DIPROPYLENE GLYCOL
Product Characteristics
Color Score
Shape ROUND Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1630-7 8 POUCH in 1 CARTON contains a POUCH (69238-1630-1)
1 NDC:69238-1630-1 1 d in 1 POUCH This package is contained within the CARTON (69238-1630-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211293 02/04/2019
ESTRADIOL estradiol patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1631
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.05 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)
OLEYL ALCOHOL
POVIDONE
DIPROPYLENE GLYCOL
Product Characteristics
Color Score
Shape ROUND Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1631-7 8 POUCH in 1 CARTON contains a POUCH (69238-1631-1)
1 NDC:69238-1631-1 1 d in 1 POUCH This package is contained within the CARTON (69238-1631-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211293 02/04/2019
ESTRADIOL estradiol patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1632
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.075 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)
OLEYL ALCOHOL
POVIDONE
DIPROPYLENE GLYCOL
Product Characteristics
Color Score
Shape ROUND Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1632-7 8 POUCH in 1 CARTON contains a POUCH (69238-1632-1)
1 NDC:69238-1632-1 1 d in 1 POUCH This package is contained within the CARTON (69238-1632-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211293 02/04/2019
ESTRADIOL estradiol patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1633
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.1 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)
OLEYL ALCOHOL
POVIDONE
DIPROPYLENE GLYCOL
Product Characteristics
Color Score
Shape ROUND Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1633-7 8 POUCH in 1 CARTON contains a POUCH (69238-1633-1)
1 NDC:69238-1633-1 1 d in 1 POUCH This package is contained within the CARTON (69238-1633-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211293 02/04/2019
Labeler — Amneal Pharmaceuticals NY LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals, LLC 053542455 ANALYSIS (69238-1633), ANALYSIS (69238-1629), ANALYSIS (69238-1630), ANALYSIS (69238-1631), ANALYSIS (69238-1632), LABEL (69238-1633), LABEL (69238-1629), LABEL (69238-1630), LABEL (69238-1631), LABEL (69238-1632), MANUFACTURE (69238-1633), MANUFACTURE (69238-1629), MANUFACTURE (69238-1630), MANUFACTURE (69238-1631), MANUFACTURE (69238-1632), PACK (69238-1633), PACK (69238-1629), PACK (69238-1630), PACK (69238-1631), PACK (69238-1632)

Revised: 12/2020 Amneal Pharmaceuticals NY LLC

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