NDC 68180-829

AMABELZ

Estradiol And Norethindrone Acetate

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

Product ID68180-829_28ead69b-4f95-4528-9c17-a0eca870cf0d
NDC68180-829
Product TypeHuman Prescription Drug
Proprietary NameAMABELZ
Generic NameEstradiol And Norethindrone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-10-08
Marketing CategoryANDA / ANDA
Application NumberANDA203339
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameESTRADIOL; NORETHINDRONE
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 Through2021-12-31

Packaging

NDC 68180-829-73

3 POUCH in 1 CARTON (68180-829-73) > 1 BLISTER PACK in 1 POUCH (68180-829-71) > 28 TABLET in 1 BLISTER PACK
Marketing Start Date2020-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-829-13 [68180082913]

AMABELZ TABLET
Marketing CategoryANDA
Application NumberANDA203339
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-21

NDC 68180-829-11 [68180082911]

AMABELZ TABLET
Marketing CategoryANDA
Application NumberANDA203339
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-21

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.5 mg/1

OpenFDA Data

SPL SET ID:3b8a7426-6f1c-470a-ac36-b8465b8679cd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359126
  • 1359127
  • 1359124
  • 1359123
  • 1806684
  • 1806683

    • Pharmacological Class

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

    Medicade Reported Pricing

    68180082913 AMABELZ 0.5 MG-0.1 MG TABLET

    Pricing Unit: EA | Drug Type:

    68180082911 AMABELZ 0.5 MG-0.1 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    68180-829AMABELZestradiol and norethindrone acetate
    68180-830AMABELZestradiol and norethindrone acetate
    60846-201Activellaestradiol and norethindrone acetate
    60846-202Activellaestradiol 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 [AMABELZ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AMABELZ
    AMABELZ
    87100819 5287570 Live/Registered
    Lupin Limited
    2016-07-12
    AMABELZ
    AMABELZ
    85830099 not registered Dead/Abandoned
    Lupin Limited
    2013-01-23
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.