NDC 0378-7292

NORETHINDRONE

Norethindrone

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

Product ID0378-7292_7f0eb86b-9fc3-408e-90ae-707cc7d20f18
NDC0378-7292
Product TypeHuman Prescription Drug
Proprietary NameNORETHINDRONE
Generic NameNorethindrone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-07-12
Marketing CategoryANDA / ANDA
Application NumberANDA201483
Labeler NameMylan Pharmaceuticals Inc.
Substance NameNORETHINDRONE
Active Ingredient Strength0 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-7292-53

3 POUCH in 1 CARTON (0378-7292-53) > 1 BLISTER PACK in 1 POUCH (0378-7292-85) > 28 TABLET in 1 BLISTER PACK
Marketing Start Date2013-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-7292-85 [00378729285]

NORETHINDRONE TABLET
Marketing CategoryANDA
Application NumberANDA201483
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-23

NDC 0378-7292-53 [00378729253]

NORETHINDRONE TABLET
Marketing CategoryANDA
Application NumberANDA201483
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-12

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE.35 mg/1

OpenFDA Data

SPL SET ID:af851d82-b30f-463b-9dba-0437225dc1ee
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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