NDC 0179-0227

Norethindrone Acetate

Norethindrone Acetate

Norethindrone Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Kaiser Foundation Hospitals. The primary component is Norethindrone Acetate.

Product ID0179-0227_7b35c3c2-597a-8d26-e053-2991aa0a2994
NDC0179-0227
Product TypeHuman Prescription Drug
Proprietary NameNorethindrone Acetate
Generic NameNorethindrone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-03-01
Marketing End Date2020-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA091090
Labeler NameKAISER FOUNDATION HOSPITALS
Substance NameNORETHINDRONE ACETATE
Active Ingredient Strength5 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN

Packaging

NDC 0179-0227-88

2400 TABLET in 1 BOTTLE (0179-0227-88)
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0179-0227-70 [00179022770]

Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA091090
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01
Marketing End Date2019-03-31

NDC 0179-0227-88 [00179022788]

Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA091090
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01
Marketing End Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE5 mg/1

OpenFDA Data

SPL SET ID:92c3793f-60ea-4b20-9e60-c1486520e61a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000405
  • Pharmacological Class

    • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.