NDC 0555-9025

Junel 21 Day

Norethindrone Acetate And Ethinyl Estradiol

Junel 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 Acetate; Ethinyl Estradiol.

Product ID0555-9025_52325c06-cbb8-4212-8d50-ae0578642b61
NDC0555-9025
Product TypeHuman Prescription Drug
Proprietary NameJunel 21 Day
Generic NameNorethindrone Acetate And Ethinyl Estradiol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-09-18
Marketing CategoryANDA / ANDA
Application NumberANDA076380
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameNORETHINDRONE ACETATE; ETHINYL ESTRADIOL
Active Ingredient Strength1 mg/1; ug/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0555-9025-42

3 POUCH in 1 CARTON (0555-9025-42) > 1 BLISTER PACK in 1 POUCH > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2003-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0555-9025-42 [00555902542]

Junel 21 Day TABLET
Marketing CategoryANDA
Application NumberANDA076380
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-09-18

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE1 mg/1

OpenFDA Data

SPL SET ID:8b82ad14-580c-4145-b825-dce849f95363
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1358765
  • 1359028
  • 1358763
  • 1358762
  • 1359023
  • 1359022
  • 259176
  • 1358780
  • 1359025
  • 1359030
  • 1358776
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-3122Jintelinorethindrone acetate and ethinyl estradiol
    0555-9025JunelNorethindrone Acetate and Ethinyl Estradiol
    0555-9027JunelNorethindrone Acetate and Ethinyl Estradiol
    51285-127LoestrinNorethindrone Acetate and Ethinyl Estradiol
    51285-131LoestrinNorethindrone Acetate and Ethinyl Estradiol
    51862-007MICROGESTIN 1/20norethindrone acetate and ethinyl estradiol
    0378-7274NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    0378-7280NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    0378-7283NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    0378-7288NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    50090-2478NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    50090-3395NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    50102-128TARINA Fe 1/20norethindrone acetate and ethinyl estradiol
    21695-685Tilia FeNorethindrone Acetate and Ethinyl Estradiol
    0555-9032Tri-Legest FeNorethindrone Acetate and Ethinyl Estradiol

    Trademark Results [Junel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JUNEL
    JUNEL
    76548497 2886089 Live/Registered
    Barr Laboratories, Inc.
    2003-10-02

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