NDC 69238-1609

LOPREEZA

Estradiol/norethindrone Acetate

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

Product ID69238-1609_088f747e-f995-4f15-80f4-b72504ffbc36
NDC69238-1609
Product TypeHuman Prescription Drug
Proprietary NameLOPREEZA
Generic NameEstradiol/norethindrone Acetate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-01-07
Marketing CategoryNDA / NDA
Application NumberNDA020907
Labeler NameAmneal Pharmaceuticals NY 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 Through2020-12-31

Packaging

NDC 69238-1609-6

1 BLISTER PACK in 1 CARTON (69238-1609-6) > 28 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69238-1609-6 [69238160906]

LOPREEZA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020907
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-07
Marketing End Date2020-01-16

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.5 mg/1

OpenFDA Data

SPL SET ID:966ac064-9eb7-4d15-b271-a7880ed1e79a
Manufacturer
UNII
UPC Code
  • 0369238161069
  • 0369238160963

    • Pharmacological Class

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

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

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

    Trademark Results [LOPREEZA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LOPREEZA
    LOPREEZA
    86321948 4690032 Live/Registered
    Amneal Pharmaceuticals LLC
    2014-06-26
    LOPREEZA
    LOPREEZA
    86082169 not registered Dead/Abandoned
    Amneal Pharmaceuticals, LLC
    2013-10-03
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