Duavee

Product NDC: 63539-112
11-digit product format: 635390112
Labeler code: 63539
Product ID: 63539-112_efdd202d-1033-4fb9-bd7f-f35d9b885676
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: 0000-00-00
Substance: ESTROGENS, CONJUGATED; BAZEDOXIFENE ACETATE
Active strength: 0 mg/1; mg/1
Pharmacologic classes: Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS],Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63539-112		D	Discontinued by firm		2026-08-11
excluded package	package	63539-112	63539-112-07	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63539-112-07	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63539-112-07	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63539-112-07	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63539-112-07	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63539-112-07	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63539-112-07	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63539-112-07	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63539-112-07	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63539-112-07	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63539-112-07	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63539-112-07	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63539-112-07	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63539-112-07	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63539-112-07	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63539-112-07	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63539-112-07	2021-02-06	C162847	48780-1	9855e2a2-359a-60a7-e053-dbdaa90a05bd	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
63539-112-07	2019-11-27	C162847	48780-1	9855e2a2-359a-60a7-e053-dbdaa90a05bd	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

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

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
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
IU5QR144QX	ESTROGENS, CONJUGATED	12126-59-9	ESTROGENS, CONJUGATED
J70472UD3D	BAZEDOXIFENE ACETATE	198481-33-3	BAZEDOXIFENE ACETATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Duavee	U.S. Pharmaceuticals \| Wyeth Pharmaceuticals Inc. \| Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. \| Pfizer Ireland Pharmaceuticals \| Pfizer Pharmaceuticals LLC	2013-11-06	HUMAN PRESCRIPTION DRUG LABEL	1