NDC 50102-200

Tulana

Norethindrone

Tulana is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Afaxys Pharma, Llc. The primary component is Norethindrone.

Product ID50102-200_12863d59-3883-4dda-b058-27aac1d29cfd
NDC50102-200
Product TypeHuman Prescription Drug
Proprietary NameTulana
Generic NameNorethindrone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-09-23
Marketing CategoryANDA / ANDA
Application NumberANDA207304
Labeler NameAfaxys Pharma, LLC
Substance NameNORETHINDRONE
Active Ingredient Strength0 mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50102-200-13

3 PACKAGE in 1 CARTON (50102-200-13) > 1 BLISTER PACK in 1 PACKAGE (50102-200-11) > 28 TABLET in 1 BLISTER PACK (50102-200-01)
Marketing Start Date2016-09-23
Marketing End Date2022-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50102-200-13 [50102020013]

Tulana TABLET
Marketing CategoryANDA
Application NumberANDA207304
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-23

NDC 50102-200-11 [50102020011]

Tulana TABLET
Marketing CategoryANDA
Application NumberANDA207304
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-23

NDC 50102-200-01 [50102020001]

Tulana TABLET
Marketing CategoryANDA
Application NumberANDA207304
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-21

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE.35 mg/1

OpenFDA Data

SPL SET ID:afd4d5c4-cc99-4679-8790-474644e7c1f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198042
  • 2043465
  • 748961

    • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]

    Medicade Reported Pricing

    50102020013 TULANA 0.35 MG TABLET

    Pricing Unit: EA | Drug Type:

    50102020011 TULANA 0.35 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    50102-200TulanaNORETHINDRONE
    53002-2687TulanaNORETHINDRONE
    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
    50458-194Ortho MicronorNORETHINDRONE
    16714-441SHAROBELNorethindrone

    Trademark Results [Tulana]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TULANA
    TULANA
    87777573 not registered Live/Pending
    Afaxys, Inc.
    2018-01-31
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