NDC 75834-129

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 Nivagen Pharmaceuticals, Inc.. The primary component is Norethindrone Acetate; Ethinyl Estradiol.

Product ID75834-129_8db5310b-ec90-4851-9212-81f05b217825
NDC75834-129
Product TypeHuman Prescription Drug
Proprietary NameNorethindrone Acetate and Ethinyl Estradiol
Generic NameNorethindrone Acetate And Ethinyl Estradiol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-11-25
Marketing CategoryANDA / ANDA
Application NumberANDA203435
Labeler NameNivagen Pharmaceuticals, Inc.
Substance NameNORETHINDRONE ACETATE; 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 Through2021-12-31

Packaging

NDC 75834-129-29

3 BLISTER PACK in 1 CARTON (75834-129-29) > 28 TABLET in 1 BLISTER PACK (75834-129-84)
Marketing Start Date2016-11-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75834-129-84 [75834012984]

Norethindrone Acetate and Ethinyl Estradiol TABLET
Marketing CategoryANDA
Application NumberANDA203435
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-25

NDC 75834-129-29 [75834012929]

Norethindrone Acetate and Ethinyl Estradiol TABLET
Marketing CategoryANDA
Application NumberANDA203435
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-25

NDC 75834-129-90 [75834012990]

Norethindrone Acetate and Ethinyl Estradiol TABLET
Marketing CategoryANDA
Application NumberANDA203435
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-25

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE.5 mg/1

OpenFDA Data

SPL SET ID:2c2a37e1-adaf-4947-abb1-736bfa58bf98
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1251323
  • 1090992
  • 1251334
  • 1251336

    • Pharmacological Class

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

    Medicade Reported Pricing

    75834012929 NORETHIND-ETH ESTRAD 0.5-2.5

    Pricing Unit: EA | Drug Type:

    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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