NDC 65862-715

Norethindrone acetate

Norethindrone Acetate

Norethindrone acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Norethindrone Acetate.

Product ID65862-715_4253fcb8-1ba7-4d49-817b-259650f883f9
NDC65862-715
Product TypeHuman Prescription Drug
Proprietary NameNorethindrone acetate
Generic NameNorethindrone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-01-08
Marketing CategoryANDA / ANDA
Application NumberANDA204236
Labeler NameAurobindo Pharma Limited
Substance NameNORETHINDRONE ACETATE
Active Ingredient Strength5 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65862-715-50

50 TABLET in 1 BOTTLE (65862-715-50)
Marketing Start Date2016-01-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-715-50 [65862071550]

Norethindrone acetate TABLET
Marketing CategoryANDA
Application NumberANDA204236
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-08
Marketing End Date2019-12-30

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE5 mg/1

OpenFDA Data

SPL SET ID:d7f6e734-b8c2-4d85-86bc-c7cb24502922
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000405
  • UPC Code
  • 0365862715500
  • 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

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