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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022247-001	DUAVEE	BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED	EQ 20MG BASE;0.45MG	TABLET / ORAL		RLD, RS	2013-10-03

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31
N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Duavee

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTROGENS, CONJUGATED	20 mg/1
BAZEDOXIFENE ACETATE	.45 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IU5QR144QX	Internal UNII lookup
J70472UD3D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1441392	Internal RxNorm lookup
1441740	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e16705d8-4472-4f83-96ac-69fa2be066cb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d95be220-b30e-4165-a12d-f83825b0efb1	Product name	1	20160111
882e78d5-69f7-4a43-812f-1c1628241bbc	Product name	1	20150910
2e1ce74f-4938-37b4-e2b4-cfd7971b45ea	Product name	1	20140508
d90784c3-64a2-2f23-9acd-d948d25bf235	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63539-122-07	Duavee	1 in 1 CARTON	TABLET, FILM COATED	1		12
63539-122-07	Duavee	7 in 1 BLISTER PACK	TABLET, FILM COATED	7		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BAZEDOXIFENE ACETATE	ACTIVE INGREDIENT	J70472UD3D	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
ESTROGENS, CONJUGATED	ACTIVE INGREDIENT	IU5QR144QX	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
BAZEDOXIFENE	ACTIVE MOIETY	Q16TT9C5BK	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
ESTROGENS, CONJUGATED	ACTIVE MOIETY	IU5QR144QX	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	INACTIVE INGREDIENT	R33S7TK2EP	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
HYPROMELLOSE 2208 (100000 MPA.S)	INACTIVE INGREDIENT	VM7F0B23ZI	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
SUCROSE PALMITATE	INACTIVE INGREDIENT	3OSQ643ZK5	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63539-122	DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	10	Current NDC, Legacy NDC, 2 package rows	20250112_e16705d8-4472-4f83-96ac-69fa2be066cb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duavee	CONJUGATED ESTROGENS/BAZEDOXIFENE	U.S. Pharmaceuticals	e16705d8-4472-4f83-96ac-69fa2be066cb	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022247 application number: NDA022247 ndc (product): 63539-122
Duavee	CONJUGATED ESTROGENS/BAZEDOXIFENE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	e1b75458-2e5b-46b9-92c6-fa6daba3770f	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022247 application number: NDA022247

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J70472UD3D	BAZEDOXIFENE ACETATE	198481-33-3	BAZEDOXIFENE ACETATE
IU5QR144QX	ESTROGENS, CONJUGATED	12126-59-9	ESTROGENS, CONJUGATED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1441740	Duavee 0.45 MG / 20 MG Oral Tablet	PSN	e16705d8-4472-4f83-96ac-69fa2be066cb	12
1441392	estrogens, conjugated 0.45 MG / bazedoxifene acetate 20 MG Oral Tablet	PSN	e16705d8-4472-4f83-96ac-69fa2be066cb	12
1441740	bazedoxifene 20 MG / estrogens, conjugated (USP) 0.45 MG Oral Tablet [Duavee]	SBD	e16705d8-4472-4f83-96ac-69fa2be066cb	12
1441392	bazedoxifene 20 MG / estrogens, conjugated (USP) 0.45 MG Oral Tablet	SCD	e16705d8-4472-4f83-96ac-69fa2be066cb	12
1441392	bazedoxifene 20 MG (as bazedoxifene acetate 22.6 MG) / estrogens, conjugated (USP) 0.45 MG Oral Tablet	SY	e16705d8-4472-4f83-96ac-69fa2be066cb	12
1441740	Duavee (estrogens, conjugated 0.45 MG) / bazedoxifene 20 MG (as 22.6 mg bazedoxifene acetate) Oral Tablet	SY	e16705d8-4472-4f83-96ac-69fa2be066cb	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63539-122-07	63539012207	1 BLISTER PACK in 1 CARTON (63539-122-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2013-11-15	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duavee	U.S. Pharmaceuticals \| Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Canada ULC	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	13