NDC 60846-201

Activella

Estradiol And Norethindrone Acetate

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

Product ID60846-201_a5109fb8-c0d8-4416-a795-3381b3831109
NDC60846-201
Product TypeHuman Prescription Drug
Proprietary NameActivella
Generic NameEstradiol And Norethindrone Acetate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-05-12
Marketing End Date2019-08-31
Marketing CategoryNDA / NDA
Application NumberNDA020907
Labeler NameGemini Laboratories, 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

Packaging

NDC 60846-201-01

1 DIALPACK in 1 CARTON (60846-201-01) > 28 TABLET, FILM COATED in 1 DIALPACK
Marketing Start Date2016-05-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60846-201-01 [60846020101]

Activella TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020907
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-12
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.5 mg/1

OpenFDA Data

SPL SET ID:32a9f9a3-2940-251a-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359126
  • 1359127
  • 1359124
  • 1359125
  • 1359123
  • 1359128
    • UPC Code
  • 0360846202014
  • 0360846201017

    • Pharmacological Class

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

    Medicade Reported Pricing

    60846020101 ACTIVELLA 0.5-0.1 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    60846-201Activellaestradiol and norethindrone acetate
    60846-202Activellaestradiol and norethindrone acetate
    60846-231ActivellaEstradiol/norethindrone acetate
    60846-232ActivellaEstradiol/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
    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
    0093-5455MimveyEstradiol and Norethindrone Acetate
    0093-5454Mimvey LoEstradiol and 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.