NDC 51285-131

Loestrin 21 Day

Norethindrone Acetate And Ethinyl Estradiol

Loestrin 21 Day is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Teva Women's Health, Inc.. The primary component is Ethinyl Estradiol; Norethindrone Acetate.

Product ID51285-131_636a253c-cc1c-4e19-99c8-a9cca597a891
NDC51285-131
Product TypeHuman Prescription Drug
Proprietary NameLoestrin 21 Day
Generic NameNorethindrone Acetate And Ethinyl Estradiol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-02-26
Marketing CategoryANDA / ANDA
Application NumberANDA076380
Labeler NameTeva Women's Health, Inc.
Substance NameETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active Ingredient Strength20 ug/1; mg/1
Pharm ClassesEstrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 51285-131-97

5 POUCH in 1 CARTON (51285-131-97) > 1 BLISTER PACK in 1 POUCH > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2015-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51285-131-97 [51285013197]

Loestrin 21 Day TABLET
Marketing CategoryANDA
Application NumberANDA076380
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-26

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE1 mg/1

OpenFDA Data

SPL SET ID:f29ebcb5-7e65-4092-bfaa-f5ec026fc255
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1358776
  • 1359028
  • 1358763
  • 1358762
  • 1359023
  • 259176
  • 1358781
  • 1359026
  • 1359022
  • 1358770
  • 1359031
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Loestrin 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 [Loestrin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LOESTRIN
    LOESTRIN
    80960286 0960286 Dead/Cancelled
    Parke Davis Laboratories
    0000-00-00
    LOESTRIN
    LOESTRIN
    73234493 1156945 Live/Registered
    Parke Davis Laboratories
    1979-10-09

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