NDC 50458-194

Ortho Micronor

Norethindrone

Ortho Micronor is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Norethindrone.

Product ID50458-194_86d3d5c2-638b-11ea-aebd-792bfc2ca371
NDC50458-194
Product TypeHuman Prescription Drug
Proprietary NameOrtho Micronor
Generic NameNorethindrone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1973-01-02
Marketing End Date2025-05-31
Marketing CategoryNDA / NDA
Application NumberNDA016954
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameNORETHINDRONE
Active Ingredient Strength0 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN

Packaging

NDC 50458-194-06

6 BLISTER PACK in 1 CARTON (50458-194-06) > 28 TABLET in 1 BLISTER PACK (50458-194-28)
Marketing Start Date2018-02-01
Marketing End Date2021-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-194-28 [50458019428]

Ortho Micronor TABLET
Marketing CategoryNDA
Application NumberNDA016954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-05
Marketing End Date2025-05-31

NDC 50458-194-23 [50458019423]

Ortho Micronor TABLET
Marketing CategoryNDA
Application NumberNDA016954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1973-01-02
Marketing End Date2019-06-30

NDC 50458-194-00 [50458019400]

Ortho Micronor TABLET
Marketing CategoryNDA
Application NumberNDA016954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1973-01-02
Marketing End Date2025-05-31

NDC 50458-194-06 [50458019406]

Ortho Micronor TABLET
Marketing CategoryNDA
Application NumberNDA016954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-01
Marketing End Date2021-04-30

NDC 50458-194-16 [50458019416]

Ortho Micronor TABLET
Marketing CategoryNDA
Application NumberNDA016954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1973-01-02
Marketing End Date2020-05-31

NDC 50458-194-12 [50458019412]

Ortho Micronor TABLET
Marketing CategoryNDA
Application NumberNDA016954
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-10
Marketing End Date2020-05-31

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE.35 mg/1

OpenFDA Data

SPL SET ID:cc1fd49c-ba64-445e-8d03-f771a7439503
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 748987
  • 198042
  • 748961
  • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]

    Medicade Reported Pricing

    50458019428 ORTHO MICRONOR 0.35 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458019423 ORTHO MICRONOR 0.35 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458019416 ORTHO MICRONOR 0.35 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458019412 ORTHO MICRONOR 0.35 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458019406 ORTHO MICRONOR 0.35 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458019400 ORTHO MICRONOR 0.35 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Ortho Micronor" or generic name "Norethindrone"

    NDCBrand NameGeneric Name
    50458-194Ortho MicronorNORETHINDRONE
    51862-102CamilaNorethindrone
    51862-884CAMILANORETHINDRONE
    16714-440DEBLITANENorethindrone
    0555-0344ErrinNorethindrone
    51862-100ErrinNorethindrone
    51862-886ERRINNORETHINDRONE
    57297-877Jencyclanorethindrone
    52544-892JolivetteNORETHINDRONE
    50102-300LyleqNORETHINDRONE
    53002-1793LyleqNORETHINDRONE
    50102-100LYZAnorethindrone
    53002-1687LYZAnorethindrone
    52544-629Nora BENorethindrone
    0378-7272NorethindroneNorethindrone
    0378-7292NORETHINDRONEnorethindrone
    50090-2150NorethindroneNorethindrone
    50090-6161NORETHINDRONENORETHINDRONE
    57297-876NORETHINDRONENORETHINDRONE
    63187-748NorethindroneNorethindrone
    42291-650Norethindrone AcetateNorethindrone
    50268-602Norethindrone AcetateNorethindrone
    50090-3235Norlydanorethindrone
    51660-127NORLYROCnorethindrone
    16714-441SHAROBELNorethindrone
    50102-200TulanaNORETHINDRONE
    53002-2687TulanaNORETHINDRONE

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.