NDC 0555-9009

Nortrel 21 Day

Norethindrone And Ethinyl Estradiol

Nortrel 21 Day is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Norethindrone; Ethinyl Estradiol.

Product ID0555-9009_5bde6242-a078-49f9-9105-e3d471101d21
NDC0555-9009
Product TypeHuman Prescription Drug
Proprietary NameNortrel 21 Day
Generic NameNorethindrone And Ethinyl Estradiol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-06-13
Marketing CategoryANDA / ANDA
Application NumberANDA072693
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameNORETHINDRONE; ETHINYL ESTRADIOL
Active Ingredient Strength1 mg/1; mg/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0555-9009-42

3 POUCH in 1 CARTON (0555-9009-42) > 1 BLISTER PACK in 1 POUCH (0555-9009-80) > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2001-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0555-9009-42 [00555900942]

Nortrel 21 Day TABLET
Marketing CategoryANDA
Application NumberANDA072693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-06-13

NDC 0555-9009-57 [00555900957]

Nortrel 21 Day TABLET
Marketing CategoryANDA
Application NumberANDA072693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-06-13
Marketing End Date2014-01-14

NDC 0555-9009-80 [00555900980]

Nortrel 21 Day TABLET
Marketing CategoryANDA
Application NumberANDA072693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-15

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE1 mg/1

OpenFDA Data

SPL SET ID:140c50d6-c931-423a-9aa0-526eae7ab93c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 748797
  • 310463
  • 751870
  • 751871
  • 749858
  • 751868
  • 749879
  • 749869
  • 312033

    • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]
    • Estrogen Receptor Agonists [MoA]
    • Estrogen [EPC]

    NDC Crossover Matching brand name "Nortrel 21 Day" or generic name "Norethindrone And Ethinyl Estradiol"

    NDCBrand NameGeneric Name
    50090-1477ALYACEN 1/35norethindrone and ethinyl estradiol
    50090-1478ALYACEN 7/7/7norethindrone and ethinyl estradiol
    0555-9066Aranellenorethindrone and ethinyl estradiol
    0555-9034BalzivaNorethindrone and Ethinyl Estradiol
    0603-7521Cyclafem 1/35norethindrone and ethinyl estradiol
    0603-7525Cyclafem 7/7/7norethindrone and ethinyl estradiol
    16714-348Dasetta 1/35Norethindrone and Ethinyl Estradiol
    16714-346Dasetta 7/7/7norethindrone and ethinyl estradiol
    21695-857NeconNorethindrone and Ethinyl Estradiol
    0093-3303Necon 1/35Norethindrone and Ethinyl Estradiol
    0555-9008NortrelNorethindrone and Ethinyl Estradiol
    0555-9009NortrelNorethindrone and Ethinyl Estradiol
    0555-9010NortrelNorethindrone and Ethinyl Estradiol
    0555-9012Nortrel 7/7/7Norethindrone and Ethinyl Estradiol
    50090-0159Ortho-Novumnorethindrone and ethinyl estradiol
    16714-370Weranorethindrone and ethinyl estradiol
    50090-1431WeraNorethindrone and Ethinyl Estradiol

    Trademark Results [Nortrel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NORTREL
    NORTREL
    75803003 2632298 Live/Registered
    BARR LABORATORIES, INC.
    1999-09-16
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