Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products4
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
54868-3799Application Number
NDA020527Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 1, 2012SHELLACInactive
Code: 46N107B71OClass: IACT
GLYCERYL MONOOLEATEInactive
Code: 4PC054V79PClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4JClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CALCIUM SULFATEInactive
Code: WAT0DDB505Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIBQuantity: 0.625 mg in 1 1
Code: C2QI4IOI2GClass: ACTIBQuantity: 2.5 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Prempro
Product Details
NDC Product Code
54868-5047Application Number
NDA020527Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 1, 2012HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIBQuantity: 0.3 mg in 1 1
Code: C2QI4IOI2GClass: ACTIBQuantity: 1.5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: 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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
Prempro
Product Details
NDC Product Code
54868-4866Application Number
NDA020527Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 1, 2012FERROSOFERRIC 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
Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIBQuantity: 0.45 mg in 1 1
Code: C2QI4IOI2GClass: ACTIBQuantity: 1.5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Prempro
Product Details
NDC Product Code
54868-5540Application Number
NDA020527Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 1, 2012CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4JClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIBQuantity: 0.625 mg in 1 1
Code: C2QI4IOI2GClass: ACTIBQuantity: 5 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CALCIUM SULFATEInactive
Code: WAT0DDB505Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
GLYCERYL MONOOLEATEInactive
Code: 4PC054V79PClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT