NDC 0378-7291

Norethindrone Acetate

Norethindrone Acetate

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 Norethindrone Acetate.

Product ID0378-7291_4e8e531a-dac2-44ce-b06b-390296c26833
NDC0378-7291
Product TypeHuman Prescription Drug
Proprietary NameNorethindrone Acetate
Generic NameNorethindrone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-19
Marketing CategoryANDA / ANDA
Application NumberANDA205278
Labeler NameMylan Pharmaceuticals Inc.
Substance NameNORETHINDRONE ACETATE
Active Ingredient Strength5 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-7291-89

50 TABLET in 1 BOTTLE (0378-7291-89)
Marketing Start Date2019-07-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-7291-89 [00378729189]

Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA205278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-19

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE5 mg/1

OpenFDA Data

SPL SET ID:4e8e531a-dac2-44ce-b06b-390296c26833
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000405
  • UPC Code
  • 0303787291891
  • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]
    • Progesterone Congeners [CS]
    • Progestin [EPC]

    NDC Crossover Matching brand name "Norethindrone Acetate" or generic name "Norethindrone Acetate"

    NDCBrand NameGeneric Name
    0179-0227Norethindrone AcetateNorethindrone Acetate
    0378-7291Norethindrone AcetateNorethindrone Acetate
    0555-0211Norethindrone AcetateNorethindrone Acetate
    16571-658Norethindrone acetatenorethindrone acetate
    42291-650Norethindrone AcetateNorethindrone
    50268-602Norethindrone AcetateNorethindrone
    50742-267Norethindrone acetatenorethindrone acetate
    65162-475Norethindrone AcetateNorethindrone
    65862-715Norethindrone acetateNorethindrone acetate
    68462-304Norethindrone AcetateNorethindrone Acetate
    51285-424AygestinNorethindrone Acetate

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