Lopreeza
These highlights do not include all the information needed to use LOPREEZA safely and effectively. See full prescribing information for LOPREEZA. LOPREEZA (estradiol/norethindrone acetate) tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
bf0e39cb-95e7-4831-92d2-0b3f071aeaae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2017
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
estradiol/norethindrone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1251
Application NumberNDA020907
Product Classification
M
Marketing Category
C73605
G
Generic Name
estradiol/norethindrone acetate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2017
FDA Product Classification
INGREDIENTS (9)
NORETHINDRONE ACETATEActive
Quantity: 0.5 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ESTRADIOLActive
Quantity: 1 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
estradiol/norethindrone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1252
Application NumberNDA020907
Product Classification
M
Marketing Category
C73605
G
Generic Name
estradiol/norethindrone acetate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2017
FDA Product Classification
INGREDIENTS (9)
ESTRADIOLActive
Quantity: 0.5 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
NORETHINDRONE ACETATEActive
Quantity: 0.1 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT