NDC 68180-828

Fyavolv

Norethindrone Acetate And Ethinyl Estradiol

Fyavolv is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Ethinyl Estradiol; Norethindrone Acetate.

Product ID68180-828_4ee645be-2e7e-480e-8714-b2466a408b4b
NDC68180-828
Product TypeHuman Prescription Drug
Proprietary NameFyavolv
Generic NameNorethindrone Acetate And Ethinyl Estradiol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-03-15
Marketing CategoryANDA / ANDA
Application NumberANDA204213
Labeler NameLupin 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 Through2022-12-31

Packaging

NDC 68180-828-09

1 BOTTLE in 1 CARTON (68180-828-09) > 90 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2016-03-15
Marketing End Date2022-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-828-09 [68180082809]

Fyavolv TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204213
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-15

NDC 68180-828-13 [68180082813]

Fyavolv TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204213
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-15

NDC 68180-828-11 [68180082811]

Fyavolv TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204213
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-15

Drug Details

Active Ingredients

IngredientStrength
ETHINYL ESTRADIOL.005 mg/1

Pharmacological Class

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

Medicade Reported Pricing

68180082813 FYAVOLV 1 MG-5 MCG TABLET

Pricing Unit: EA | Drug Type:

68180082811 FYAVOLV 1 MG-5 MCG TABLET

Pricing Unit: EA | Drug Type:

68180082809 FYAVOLV 1 MG-5 MCG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Fyavolv" or generic name "Norethindrone Acetate And Ethinyl Estradiol"

NDCBrand NameGeneric Name
68180-828FyavolvFyavolv
68180-827FyavolvFyavolv
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 [Fyavolv]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FYAVOLV
FYAVOLV
85830153 5041369 Live/Registered
Lupin Limited
2013-01-23
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