NDC 51991-623

Estradiol / Norethindrone Acetate

Estradiol And Norethindrone Acetate

Estradiol / Norethindrone Acetate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Estradiol; Norethindrone Acetate.

Product ID51991-623_06de62b9-4229-4138-95f2-45bd8772aa36
NDC51991-623
Product TypeHuman Prescription Drug
Proprietary NameEstradiol / Norethindrone Acetate
Generic NameEstradiol And Norethindrone Acetate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-06-09
Marketing CategoryANDA / ANDA
Application NumberANDA078324
Labeler NameBreckenridge Pharmaceutical, 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 51991-623-28

1 BLISTER PACK in 1 CARTON (51991-623-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2011-06-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51991-623-28 [51991062328]

Estradiol / Norethindrone Acetate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078324
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-09

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.5 mg/1

OpenFDA Data

SPL SET ID:44125b2f-10ac-435c-bdb4-a29bf8450dbf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359126
  • 1359127
  • 1359124
  • 1359123
    • UPC Code
  • 0351991474289

    • Pharmacological Class

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

    Medicade Reported Pricing

    51991062328 ESTRADIOL-NORETH 0.5-0.1 MG TB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Estradiol / Norethindrone Acetate" or generic name "Estradiol And Norethindrone Acetate"

    NDCBrand NameGeneric Name
    51991-474Estradiol / Norethindrone AcetateEstradiol and Norethindrone Acetate
    51991-623Estradiol / 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
    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
    0093-5455MimveyEstradiol and Norethindrone Acetate
    0093-5454Mimvey LoEstradiol and Norethindrone Acetate
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