NDC 50742-657

Estradiol and Norethindrone Acetate

Estradiol And Norethindrone Acetate

Estradiol and Norethindrone Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Estradiol; Norethindrone Acetate.

Product ID50742-657_bb15ca3a-56be-430a-a34b-3c04b5c08aba
NDC50742-657
Product TypeHuman Prescription Drug
Proprietary NameEstradiol and Norethindrone Acetate
Generic NameEstradiol And Norethindrone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-04-03
Marketing CategoryANDA / ANDA
Application NumberANDA210612
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameESTRADIOL; NORETHINDRONE ACETATE
Active Ingredient Strength1 mg/1; mg/1
Pharm ClassesEstradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50742-657-28

1 BLISTER PACK in 1 CARTON (50742-657-28) > 28 TABLET in 1 BLISTER PACK (50742-657-01)
Marketing Start Date2019-04-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-657-28 [50742065728]

Estradiol and Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA210612
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-03

NDC 50742-657-68 [50742065768]

Estradiol and Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA210612
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-03

NDC 50742-657-01 [50742065701]

Estradiol and Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA210612
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-03

NDC 50742-657-84 [50742065784]

Estradiol and Norethindrone Acetate TABLET
Marketing CategoryANDA
Application NumberANDA210612
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-03

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL1 mg/1

Pharmacological Class

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

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

NDCBrand NameGeneric Name
0378-7294ESTRADIOL AND NORETHINDRONE ACETATEestradiol and norethindrone acetate
0378-7295ESTRADIOL AND NORETHINDRONE ACETATEestradiol and norethindrone acetate
50742-657Estradiol and Norethindrone AcetateEstradiol and Norethindrone Acetate
50742-658Estradiol and Norethindrone AcetateEstradiol and Norethindrone Acetate
60846-201Activellaestradiol and norethindrone acetate
60846-202Activellaestradiol and norethindrone acetate
68180-829AMABELZestradiol and norethindrone acetate
68180-830AMABELZestradiol and norethindrone acetate
51991-474Estradiol / Norethindrone AcetateEstradiol and Norethindrone Acetate
51991-623Estradiol / Norethindrone AcetateEstradiol and Norethindrone Acetate
0093-5455MimveyEstradiol and Norethindrone Acetate
0093-5454Mimvey LoEstradiol and Norethindrone Acetate
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.