Duavee
These highlights do not include all the information needed to use DUAVEE safely and effectively. See full prescribing information for DUAVEE. DUAVEE (conjugated estrogens/bazedoxifene) tablets for oral use Initial U.S. approval: 2013
Approved
Approval ID
e16705d8-4472-4f83-96ac-69fa2be066cb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
U.S. Pharmaceuticals
DUNS: 829076905
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
conjugated estrogens/bazedoxifene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-122
Application NumberNDA022247
Product Classification
M
Marketing Category
C73594
G
Generic Name
conjugated estrogens/bazedoxifene
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2022
FDA Product Classification
INGREDIENTS (24)
ESTROGENS, CONJUGATEDActive
Quantity: 0.45 mg in 1 1
Code: IU5QR144QX
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BAZEDOXIFENE ACETATEActive
Quantity: 20 mg in 1 1
Code: J70472UD3D
Classification: ACTIM
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SUCROSE PALMITATEInactive
Code: 3OSQ643ZK5
Classification: IACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)Inactive
Code: R33S7TK2EP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT