NDC 0378-7294

ESTRADIOL AND NORETHINDRONE ACETATE

Estradiol And Norethindrone Acetate

ESTRADIOL AND NORETHINDRONE ACETATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Estradiol; Norethindrone Acetate.

Product ID0378-7294_350e7ce6-3253-4c04-af72-835595343113
NDC0378-7294
Product TypeHuman Prescription Drug
Proprietary NameESTRADIOL AND NORETHINDRONE ACETATE
Generic NameEstradiol And Norethindrone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-07-24
Marketing CategoryANDA / ANDA
Application NumberANDA207261
Labeler NameMylan Pharmaceuticals Inc.
Substance NameESTRADIOL; NORETHINDRONE ACETATE
Active Ingredient Strength1 mg/1; mg/1
Pharm ClassesEstradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-7294-53

3 POUCH in 1 CARTON (0378-7294-53) > 1 BLISTER PACK in 1 POUCH (0378-7294-85) > 28 TABLET in 1 BLISTER PACK
Marketing Start Date2018-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-7294-85 [00378729485]

ESTRADIOL AND NORETHINDRONE ACETATE TABLET
Marketing CategoryANDA
Application NumberANDA207261
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-24

NDC 0378-7294-53 [00378729453]

ESTRADIOL AND NORETHINDRONE ACETATE TABLET
Marketing CategoryANDA
Application NumberANDA207261
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-24

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.5 mg/1

OpenFDA Data

SPL SET ID:6cafe148-bfb8-4c09-a056-b0637c0c3065
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359126
  • 1359127
  • 1359124
  • 1359123

    • Pharmacological Class

    • Estradiol Congeners [CS]
    • Estrogen [EPC]
    • Estrogen Receptor Agonists [MoA]
    • Progesterone Congeners [CS]
    • Progestin [EPC]
    • Estradiol Congeners [CS]
    • Estrogen [EPC]
    • Estrogen Receptor Agonists [MoA]
    • Progesterone Congeners [CS]
    • Progestin [EPC]

    NDC Crossover Matching brand name "ESTRADIOL AND NORETHINDRONE ACETATE" or generic name "Estradiol And Norethindrone Acetate"

    NDCBrand NameGeneric Name
    0378-7294ESTRADIOL AND NORETHINDRONE ACETATEestradiol and norethindrone acetate
    0378-7295ESTRADIOL AND NORETHINDRONE ACETATEestradiol and norethindrone acetate
    50742-657Estradiol and Norethindrone AcetateEstradiol and Norethindrone Acetate
    50742-658Estradiol and Norethindrone AcetateEstradiol and Norethindrone Acetate
    60846-201Activellaestradiol and norethindrone acetate
    60846-202Activellaestradiol and norethindrone acetate
    68180-829AMABELZestradiol and norethindrone acetate
    68180-830AMABELZestradiol and norethindrone acetate
    51991-474Estradiol / Norethindrone AcetateEstradiol and Norethindrone Acetate
    51991-623Estradiol / Norethindrone AcetateEstradiol and Norethindrone Acetate
    0093-5455MimveyEstradiol and Norethindrone Acetate
    0093-5454Mimvey LoEstradiol and Norethindrone Acetate
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