NDC 0378-7280

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Norethindrone Acetate And Ethinyl Estradiol

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Ethinyl Estradiol; Norethindrone Acetate.

Product ID0378-7280_655c169a-e0f4-44e1-b868-a6b81264ff18
NDC0378-7280
Product TypeHuman Prescription Drug
Proprietary NameNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Generic NameNorethindrone Acetate And Ethinyl Estradiol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-07-11
Marketing CategoryANDA / ANDA
Application NumberANDA202771
Labeler NameMylan Pharmaceuticals Inc.
Substance NameETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active Ingredient Strength0 mg/1; mg/1
Pharm ClassesEstrogen Receptor Agonists [MoA],Estrogen [EPC],Progesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-7280-53

3 POUCH in 1 CARTON (0378-7280-53) > 1 BLISTER PACK in 1 POUCH (0378-7280-85) > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2014-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-7280-85 [00378728085]

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
Marketing CategoryANDA
Application NumberANDA202771
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-22

NDC 0378-7280-53 [00378728053]

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
Marketing CategoryANDA
Application NumberANDA202771
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-07

Drug Details

Active Ingredients

IngredientStrength
ETHINYL ESTRADIOL.02 mg/1

OpenFDA Data

SPL SET ID:89948751-bd6e-4e9c-b87c-8782706c1097
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1358776
  • 1358762

    • Pharmacological Class

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

    NDC Crossover Matching brand name "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL" or generic name "Norethindrone Acetate And Ethinyl Estradiol"

    NDCBrand NameGeneric Name
    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
    68462-132Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl Estradiol
    68462-656Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl Estradiol
    68462-657Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl Estradiol
    70700-101Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl Estradiol
    75834-129Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl Estradiol
    75834-130Norethindrone Acetate and Ethinyl EstradiolNorethindrone Acetate and Ethinyl Estradiol
    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
    50102-128TARINA Fe 1/20norethindrone acetate and ethinyl estradiol
    21695-685Tilia FeNorethindrone Acetate and Ethinyl Estradiol
    0555-9032Tri-Legest FeNorethindrone Acetate and Ethinyl Estradiol
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