FDA.reportPublic FDA data

Duavee

Product NDC
63539-122
11-digit product format
635390122
Labeler code
63539
Product ID
63539-122_e75a782d-8aa3-43ff-b7aa-8e02cc821e7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
conjugated estrogens/bazedoxifene
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA022247
Marketing category
NDA
Marketing start
2013-11-15
Marketing end
2026-12-31
Substance
BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED
Active strength
20; .45 mg/1; mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duavee

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BAZEDOXIFENE ACETATE20 mg/1
ESTROGENS, CONJUGATED.45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ70472UD3D, IU5QR144QX
Rxcui1441392, 1441740

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d95be220-b30e-4165-a12d-f83825b0efb1Product name120160111
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
2e1ce74f-4938-37b4-e2b4-cfd7971b45eaProduct name120140508
d90784c3-64a2-2f23-9acd-d948d25bf235Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63539-122-07Duavee1 in 1 CARTONTABLET, FILM COATED112
63539-122-07Duavee7 in 1 BLISTER PACKTABLET, FILM COATED712

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BAZEDOXIFENE ACETATEACTIVE INGREDIENTJ70472UD3DDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
ESTROGENS, CONJUGATEDACTIVE INGREDIENTIU5QR144QXDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
BAZEDOXIFENEACTIVE MOIETYQ16TT9C5BKDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
ESTROGENS, CONJUGATEDACTIVE MOIETYIU5QR144QXDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
HYPROMELLOSE 2208 (100000 MPA.S)INACTIVE INGREDIENTVM7F0B23ZIDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
MALTITOLINACTIVE INGREDIENTD65DG142WKDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
SUCROSEINACTIVE INGREDIENTC151H8M554DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
SUCROSE PALMITATEINACTIVE INGREDIENT3OSQ643ZK5DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63539-122DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]10Current NDC, Legacy NDC, 2 package rows20250112_e16705d8-4472-4f83-96ac-69fa2be066cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1441740Duavee 0.45 MG / 20 MG Oral TabletPSNe16705d8-4472-4f83-96ac-69fa2be066cb12
1441392estrogens, conjugated 0.45 MG / bazedoxifene acetate 20 MG Oral TabletPSNe16705d8-4472-4f83-96ac-69fa2be066cb12
1441740bazedoxifene 20 MG / estrogens, conjugated (USP) 0.45 MG Oral Tablet [Duavee]SBDe16705d8-4472-4f83-96ac-69fa2be066cb12
1441392bazedoxifene 20 MG / estrogens, conjugated (USP) 0.45 MG Oral TabletSCDe16705d8-4472-4f83-96ac-69fa2be066cb12
1441392bazedoxifene 20 MG (as bazedoxifene acetate 22.6 MG) / estrogens, conjugated (USP) 0.45 MG Oral TabletSYe16705d8-4472-4f83-96ac-69fa2be066cb12
1441740Duavee (estrogens, conjugated 0.45 MG) / bazedoxifene 20 MG (as 22.6 mg bazedoxifene acetate) Oral TabletSYe16705d8-4472-4f83-96ac-69fa2be066cb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63539-122-07635390122071 BLISTER PACK in 1 CARTON (63539-122-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2013-11-150000-00-00YesNoCurrent