Premphase

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

fd0c0836-5d23-2183-da81-9dc7f4287052

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 6, 2025

Manufacturers

FDA

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

DUNS: 113008515

Products 5

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 Code0046-1108

Application NumberNDA020527

Product Classification

Marketing Category

C73594

Generic Name

conjugated estrogens and medroxyprogesterone acetate

Product Specifications

Route of AdministrationORAL

Effective DateMay 6, 2025

FDA Product Classification

INGREDIENTS (19)

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

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

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

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

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0046-1105

Application NumberNDA020527

Product Classification

Marketing Category

C73594

Generic Name

conjugated estrogens and medroxyprogesterone acetate

Product Specifications

Route of AdministrationORAL

Effective DateMay 6, 2025

FDA Product Classification

INGREDIENTS (18)

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

TRIBASIC CALCIUM PHOSPHATEInactive

Code: 91D9GV0Z28

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

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

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0046-1107

Application NumberNDA020527

Product Classification

Marketing Category

C73594

Generic Name

conjugated estrogens and medroxyprogesterone acetate

Product Specifications

Route of AdministrationORAL

Effective DateMay 6, 2025

FDA Product Classification

INGREDIENTS (18)

ESTROGENS, CONJUGATEDActive

Quantity: 0.625 mg in 1 1

Code: IU5QR144QX

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MEDROXYPROGESTERONE ACETATEActive

Quantity: 2.5 mg in 1 1

Code: C2QI4IOI2G

Classification: ACTIB

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIBASIC CALCIUM PHOSPHATEInactive

Code: 91D9GV0Z28

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0W

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0046-1106

Application NumberNDA020527

Product Classification

Marketing Category

C73594

Generic Name

conjugated estrogens and medroxyprogesterone acetate

Product Specifications

Route of AdministrationORAL

Effective DateMay 6, 2025

FDA Product Classification

INGREDIENTS (18)

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIBASIC CALCIUM PHOSPHATEInactive

Code: 91D9GV0Z28

Classification: IACT

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0W

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0046-2575

Application NumberNDA020527

Product Classification

Marketing Category

C73594

Generic Name

conjugated estrogens and medroxyprogesterone acetate

Product Specifications

Effective DateMay 6, 2025

FDA Product Classification

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Premphase

Products 5

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

conjugated estrogens and medroxyprogesterone acetate

Product Details

FDA Identifiers

Product Classification

Product Specifications

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