Premarin
PREMARIN (conjugated estrogens tablets, USP)
Approved
Approval ID
751b6213-92d8-40f8-a2d5-83e8dad086dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 18, 2012
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, Inc.
DUNS: 128385585
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
conjugated estrogens
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-688
Application NumberNDA004782
Product Classification
M
Marketing Category
C73594
G
Generic Name
conjugated estrogens
Product Specifications
Route of AdministrationORAL
Effective DateJuly 18, 2012
FDA Product Classification
INGREDIENTS (16)
ESTROGENS, CONJUGATEDActive
Quantity: 0.625 mg in 1 1
Code: IU5QR144QX
Classification: ACTIM
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
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
conjugated estrogens
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-687
Application NumberNDA004782
Product Classification
M
Marketing Category
C73594
G
Generic Name
conjugated estrogens
Product Specifications
Route of AdministrationORAL
Effective DateJuly 18, 2012
FDA Product Classification
INGREDIENTS (16)
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ESTROGENS, CONJUGATEDActive
Quantity: 0.3 mg in 1 1
Code: IU5QR144QX
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT