NDC 57297-876

NORETHINDRONE

Norethindrone

NORETHINDRONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Limited. The primary component is Norethindrone.

Product ID57297-876_200f4b92-168d-4953-9d11-fb98aa8dc398
NDC57297-876
Product TypeHuman Prescription Drug
Proprietary NameNORETHINDRONE
Generic NameNorethindrone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-11-10
Marketing CategoryANDA / ANDA
Application NumberANDA091325
Labeler NameLUPIN LIMITED
Substance NameNORETHINDRONE
Active Ingredient Strength0 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57297-876-13

3 BLISTER PACK in 1 CARTON (57297-876-13) > 28 TABLET in 1 BLISTER PACK (57297-876-11)
Marketing Start Date2011-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57297-876-11 [57297087611]

NORETHINDRONE TABLET
Marketing CategoryANDA
Application NumberANDA091325
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-10

NDC 57297-876-13 [57297087613]

NORETHINDRONE TABLET
Marketing CategoryANDA
Application NumberANDA091325
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-10
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE.35 mg/1

OpenFDA Data

SPL SET ID:a1f17fe0-4576-431a-9944-0ffe3a77c818
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198042
  • 748961
  • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]

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

    NDCBrand NameGeneric Name
    0378-7272NorethindroneNorethindrone
    0378-7292NORETHINDRONEnorethindrone
    50090-2150NorethindroneNorethindrone
    50090-6161NORETHINDRONENORETHINDRONE
    57297-876NORETHINDRONENORETHINDRONE
    63187-748NorethindroneNorethindrone
    68180-876NORETHINDRONENORETHINDRONE
    68462-305NorethindroneNorethindrone
    76413-118NorethindroneNorethindrone
    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
    42291-650Norethindrone AcetateNorethindrone
    50268-602Norethindrone AcetateNorethindrone
    50090-3235Norlydanorethindrone
    51660-127NORLYROCnorethindrone
    50458-194Ortho MicronorNORETHINDRONE
    16714-441SHAROBELNorethindrone
    50102-200TulanaNORETHINDRONE
    53002-2687TulanaNORETHINDRONE

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