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

36ec4df9-298d-4b15-9386-7848d217a46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2012

Manufacturers

FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 4

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 Code54868-3799

Application NumberNDA020527

Product Classification

Marketing Category

C73594

Generic Name

conjugated estrogens and medroxyprogesterone acetate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 1, 2012

FDA Product Classification

INGREDIENTS (17)

SHELLACInactive

Code: 46N107B71O

Classification: IACT

GLYCERYL MONOOLEATEInactive

Code: 4PC054V79P

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TRIBASIC CALCIUM PHOSPHATEInactive

Code: 91D9GV0Z28

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

METHYLCELLULOSE (100 CPS)Inactive

Code: 4GFU244C4J

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CALCIUM SULFATEInactive

Code: WAT0DDB505

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

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

SUCROSEInactive

Code: C151H8M554

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5047

Application NumberNDA020527

Product Classification

Marketing Category

C73594

Generic Name

conjugated estrogens and medroxyprogesterone acetate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 1, 2012

FDA Product Classification

INGREDIENTS (17)

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0W

Classification: IACT

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

ESTROGENS, CONJUGATEDActive

Quantity: 0.3 mg in 1 1

Code: IU5QR144QX

Classification: ACTIB

MEDROXYPROGESTERONE ACETATEActive

Quantity: 1.5 mg in 1 1

Code: C2QI4IOI2G

Classification: ACTIB

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TRIBASIC CALCIUM PHOSPHATEInactive

Code: 91D9GV0Z28

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-4866

Application NumberNDA020527

Product Classification

Marketing Category

C73594

Generic Name

conjugated estrogens and medroxyprogesterone acetate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 1, 2012

FDA Product Classification

INGREDIENTS (17)

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

ESTROGENS, CONJUGATEDActive

Quantity: 0.45 mg in 1 1

Code: IU5QR144QX

Classification: ACTIB

MEDROXYPROGESTERONE ACETATEActive

Quantity: 1.5 mg in 1 1

Code: C2QI4IOI2G

Classification: ACTIB

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5540

Application NumberNDA020527

Product Classification

Marketing Category

C73594

Generic Name

conjugated estrogens and medroxyprogesterone acetate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 1, 2012

FDA Product Classification

INGREDIENTS (17)

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

METHYLCELLULOSE (100 CPS)Inactive

Code: 4GFU244C4J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TRIBASIC CALCIUM PHOSPHATEInactive

Code: 91D9GV0Z28

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

ESTROGENS, CONJUGATEDActive

Quantity: 0.625 mg in 1 1

Code: IU5QR144QX

Classification: ACTIB

MEDROXYPROGESTERONE ACETATEActive

Quantity: 5 mg in 1 1

Code: C2QI4IOI2G

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CALCIUM SULFATEInactive

Code: WAT0DDB505

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

GLYCERYL MONOOLEATEInactive

Code: 4PC054V79P

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

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Products 4

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

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