NDC 65162-475

Norethindrone Acetate

Norethindrone

Norethindrone Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Norethindrone Acetate.

Product ID65162-475_316b0074-4116-4477-acaf-48241aa312a3
NDC65162-475
Product TypeHuman Prescription Drug
Proprietary NameNorethindrone Acetate
Generic NameNorethindrone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA200275
Labeler NameAmneal Pharmaceuticals LLC
Substance NameNORETHINDRONE ACETATE
Active Ingredient Strength5 mg/1
Pharm ClassesProgesterone Congeners [CS], Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65162-475-03

30 TABLET in 1 BOTTLE (65162-475-03)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-475-50 [65162047550]

Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA200275
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01

NDC 65162-475-05 [65162047505]

Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA200275
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-01

NDC 65162-475-03 [65162047503]

Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA200275
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01

NDC 65162-475-09 [65162047509]

Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA200275
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-01

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE5 mg/1

OpenFDA Data

SPL SET ID:64cb920c-36e8-4d62-9d08-3ddf3989d313
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000405
    • UPC Code
  • 0365162475098

    • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]

    Medicade Reported Pricing

    65162047509 NORETHINDRONE 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    65162047505 NORETHINDRONE 5 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    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
    68462-304Norethindrone AcetateNorethindrone Acetate
    65162-475Norethindrone AcetateNorethindrone Acetate
    65862-715Norethindrone acetateNorethindrone acetate
    51285-424AygestinNorethindrone Acetate
    51862-102CamilaNorethindrone
    51862-884CAMILANORETHINDRONE
    16714-440DEBLITANENorethindrone
    0555-0344ErrinNorethindrone
    51862-100ErrinNorethindrone
    51862-886ERRINNORETHINDRONE
    50102-300LyleqNORETHINDRONE
    50102-100LYZAnorethindrone
    0378-7272NorethindroneNorethindrone
    0378-7292NORETHINDRONEnorethindrone
    50090-2150NorethindroneNorethindrone
    50090-6161NORETHINDRONENORETHINDRONE
    50090-3235Norlydanorethindrone
    51660-127NORLYROCnorethindrone
    50458-194Ortho MicronorNORETHINDRONE
    16714-441SHAROBELNorethindrone
    50102-200TulanaNORETHINDRONE
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.