Prempro
These highlights do not include all the information needed to use PREMPRO/PREMPHASE safely and effectively. See full prescribing information for PREMPRO/PREMPHASE. PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE (conjugated estrogens plus medroxyprogesterone acetate tablets)Initial U.S. Approval: 1995
Approved
Approval ID
3aff3442-641c-4639-8273-cf0347d8e4c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 5, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
conjugated estrogens and medroxyprogesterone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-0573
Application NumberNDA020527
Product Classification
M
Marketing Category
C73594
G
Generic Name
conjugated estrogens and medroxyprogesterone acetate
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2019
FDA Product Classification
INGREDIENTS (18)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ESTROGENS, CONJUGATEDActive
Quantity: 0.625 mg in 1 1
Code: IU5QR144QX
Classification: ACTIB
MEDROXYPROGESTERONE ACETATEActive
Quantity: 2.5 mg in 1 1
Code: C2QI4IOI2G
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT