NDC 65862-935

Aurovela 1.5/30

Norethindrone Acetate And Ethinyl Estradiol

Aurovela 1.5/30 is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Norethindrone Acetate; Ethinyl Estradiol.

Product ID65862-935_0435aa1c-5314-4659-9832-e6e8f1dd4fda
NDC65862-935
Product TypeHuman Prescription Drug
Proprietary NameAurovela 1.5/30
Generic NameNorethindrone Acetate And Ethinyl Estradiol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-06-26
Marketing CategoryANDA / ANDA
Application NumberANDA207581
Labeler NameAurobindo Pharma Limited
Substance NameNORETHINDRONE ACETATE; ETHINYL ESTRADIOL
Active Ingredient Strength2 mg/1; ug/1
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65862-935-54

5 POUCH in 1 CARTON (65862-935-54) > 1 BLISTER PACK in 1 POUCH > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2017-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-935-54 [65862093554]

Aurovela 1.5/30 TABLET
Marketing CategoryANDA
Application NumberANDA207581
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-26

NDC 65862-935-74 [65862093574]

Aurovela 1.5/30 TABLET
Marketing CategoryANDA
Application NumberANDA207581
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-26

NDC 65862-935-21 [65862093521]

Aurovela 1.5/30 TABLET
Marketing CategoryANDA
Application NumberANDA207581
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-26
Marketing End Date2019-09-20

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE1.5 mg/1

OpenFDA Data

SPL SET ID:b146e49c-a0fc-4f3d-9ad6-99e8257fa139
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359022
  • 1359028
  • 1928007

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Aurovela 1.5/30" or generic name "Norethindrone Acetate And Ethinyl Estradiol"

    NDCBrand NameGeneric Name
    65862-935Aurovela 1.5/30Aurovela 1.5/30
    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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