NDC 16571-658

Norethindrone acetate

Norethindrone Acetate

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

Product ID16571-658_6c48c0f2-586b-48df-bb15-bff658a3b650
NDC16571-658
Product TypeHuman Prescription Drug
Proprietary NameNorethindrone acetate
Generic NameNorethindrone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-11-05
Marketing CategoryANDA / ANDA
Application NumberANDA206490
Labeler NameRising Pharmaceuticals, Inc.
Substance NameNORETHINDRONE ACETATE
Active Ingredient Strength5 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 16571-658-05

50 TABLET in 1 BOTTLE (16571-658-05)
Marketing Start Date2018-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16571-658-05 [16571065805]

Norethindrone acetate TABLET
Marketing CategoryANDA
Application NumberANDA206490
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-05

NDC 16571-658-50 [16571065850]

Norethindrone acetate TABLET
Marketing CategoryANDA
Application NumberANDA206490
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-05

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE5 mg/1

OpenFDA Data

SPL SET ID:6c48c0f2-586b-48df-bb15-bff658a3b650
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000405
  • UPC Code
  • 0316571658053
  • 0316571658503
  • 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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