NDC 60846-231

Activella

Estradiol/norethindrone Acetate

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

Product ID60846-231_5be257d4-9989-4b95-8155-b92d77a74836
NDC60846-231
Product TypeHuman Prescription Drug
Proprietary NameActivella
Generic NameEstradiol/norethindrone Acetate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-01
Marketing CategoryNDA / NDA
Application NumberNDA020907
Labeler NameAmneal Pharmaceuticals LLC
Substance NameESTRADIOL; NORETHINDRONE ACETATE
Active Ingredient Strength1 mg/1; mg/1
Pharm ClassesEstradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 60846-231-01

1 BLISTER PACK in 1 CARTON (60846-231-01) > 28 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60846-231-01 [60846023101]

Activella TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020907
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-01

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.5 mg/1

OpenFDA Data

SPL SET ID:d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359126
  • 1359127
  • 1359124
  • 1359125
  • 1359123
  • 1359128
  • UPC Code
  • 0360846232011
  • 0360846231014
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Activella" or generic name "Estradiol/norethindrone Acetate"

    NDCBrand NameGeneric Name
    60846-201Activellaestradiol and norethindrone acetate
    60846-202Activellaestradiol and norethindrone acetate
    60846-231ActivellaEstradiol/norethindrone acetate
    60846-232ActivellaEstradiol/norethindrone acetate
    69238-1251Lopreezaestradiol/norethindrone acetate
    69238-1252Lopreezaestradiol/norethindrone acetate
    69238-1609LOPREEZAestradiol/norethindrone acetate
    69238-1610LOPREEZAestradiol/norethindrone acetate

    Trademark Results [Activella]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ACTIVELLA
    ACTIVELLA
    75719159 2654685 Live/Registered
    NOVO NORDISK HEALTH CARE AG
    1999-06-01

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