NDC 65862-939

Aurovela 1/20

Norethindrone Acetate And Ethinyl Estradiol

Aurovela 1/20 is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Ethinyl Estradiol; Norethindrone Acetate.

Product ID65862-939_064efc3e-7481-4947-b2ab-a6d1e2f200db
NDC65862-939
Product TypeHuman Prescription Drug
Proprietary NameAurovela 1/20
Generic NameNorethindrone Acetate And Ethinyl Estradiol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-06-16
Marketing CategoryANDA / ANDA
Application NumberANDA207506
Labeler NameAurobindo Pharma Limited
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 65862-939-54

5 POUCH in 1 CARTON (65862-939-54) > 1 BLISTER PACK in 1 POUCH > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2017-06-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-939-21 [65862093921]

Aurovela 1/20 TABLET
Marketing CategoryANDA
Application NumberANDA207506
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-16
Marketing End Date2019-09-23

NDC 65862-939-88 [65862093988]

Aurovela 1/20 TABLET
Marketing CategoryANDA
Application NumberANDA207506
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-16

NDC 65862-939-54 [65862093954]

Aurovela 1/20 TABLET
Marketing CategoryANDA
Application NumberANDA207506
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-16

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE1 mg/1

OpenFDA Data

SPL SET ID:6765becf-7b51-4f33-ac13-70fcd01decf7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1927366
  • 1358776
  • 1358762
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Aurovela 1/20" or generic name "Norethindrone Acetate And Ethinyl Estradiol"

    NDCBrand NameGeneric Name
    65862-939Aurovela 1/20Aurovela 1/20
    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

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