Manufacturing Establishments4
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pfizer Italia S.r.l.
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
458521908
Pfizer Ireland Pharmaceuticals Unlimited Company
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
986019327
Pfizer Inc
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
943955690
Pfizer Canada ULC
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
203382973
Products5
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
0046-1108Application Number
NDA020527Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 6, 2025Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIBQuantity: 0.625 mg in 1 1
Code: C2QI4IOI2GClass: ACTIBQuantity: 5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
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
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
Prempro
Product Details
NDC Product Code
0046-1105Application Number
NDA020527Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 6, 2025MAGNESIUM 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
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28Class: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIBQuantity: 0.3 mg in 1 1
Code: C2QI4IOI2GClass: ACTIBQuantity: 1.5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: 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
Prempro
Product Details
NDC Product Code
0046-1107Application Number
NDA020527Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 6, 2025Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIBQuantity: 0.625 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Code: C2QI4IOI2GClass: ACTIBQuantity: 2.5 mg in 1 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
Prempro
Product Details
NDC Product Code
0046-1106Application Number
NDA020527Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 6, 2025Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIBQuantity: 0.45 mg in 1 1
Code: C2QI4IOI2GClass: ACTIBQuantity: 1.5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28Class: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
Premphase
Product Details
NDC Product Code
0046-2575Application Number
NDA020527Marketing Category
NDA (C73594)Effective Date
May 6, 2025