NDC 51285-424

Aygestin

Norethindrone Acetate

Aygestin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Teva Women's Health, Inc.. The primary component is Norethindrone Acetate.

Product ID51285-424_06e80ebe-6a25-4bf2-806b-b786b001141a
NDC51285-424
Product TypeHuman Prescription Drug
Proprietary NameAygestin
Generic NameNorethindrone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA075951
Labeler NameTeva Women's Health, Inc.
Substance NameNORETHINDRONE ACETATE
Active Ingredient Strength5 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51285-424-10

50 TABLET in 1 BOTTLE (51285-424-10)
Marketing Start Date2003-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51285-424-10 [51285042410]

Aygestin TABLET
Marketing CategoryANDA
Application NumberANDA075951
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-06-12

NDC 51285-424-69 [51285042469]

Aygestin TABLET
Marketing CategoryANDA
Application NumberANDA075951
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-06-12
Marketing End Date2010-08-02

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE5 mg/1

OpenFDA Data

SPL SET ID:69f5bc4b-758d-471b-ad8d-17c94f8e0963
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000407
  • 1000405
    • UPC Code
  • 0351285424105

    • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]

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

    NDCBrand NameGeneric Name
    51285-424AygestinNorethindrone Acetate
    0179-0227Norethindrone AcetateNorethindrone Acetate
    0378-7291Norethindrone AcetateNorethindrone Acetate
    0555-0211Norethindrone AcetateNorethindrone Acetate
    16571-658Norethindrone acetatenorethindrone acetate
    50742-267Norethindrone acetatenorethindrone acetate
    65862-715Norethindrone acetateNorethindrone acetate
    68462-304Norethindrone AcetateNorethindrone Acetate

    Trademark Results [Aygestin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AYGESTIN
    AYGESTIN
    73304330 1202507 Live/Registered
    American Home Products Corporation
    1981-04-03
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