Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prempro
Product Details
NDC Product Code
50090-0573Application Number
NDA020527Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 15, 2019LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIBQuantity: 0.625 mg in 1 1
Code: C2QI4IOI2GClass: ACTIBQuantity: 2.5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28Class: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT