NDC 0555-0211

Norethindrone Acetate

Norethindrone Acetate

Norethindrone Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Norethindrone Acetate.

Product ID0555-0211_3fc82f76-249d-47fd-b598-678fb98b7ec7
NDC0555-0211
Product TypeHuman Prescription Drug
Proprietary NameNorethindrone Acetate
Generic NameNorethindrone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-06-29
Marketing CategoryANDA / ANDA
Application NumberANDA075951
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameNORETHINDRONE ACETATE
Active Ingredient Strength5 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0555-0211-10

50 TABLET in 1 BOTTLE (0555-0211-10)
Marketing Start Date2001-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0555-0211-10 [00555021110]

Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA075951
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-06-29

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE5 mg/1

OpenFDA Data

SPL SET ID:f73f9807-4af6-4faa-ba9a-656a47a4c5e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000405
  • UPC Code
  • 0305550211105
  • 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

    © 2021 FDA.report
    This site is not affiliated with or endorsed by the FDA.