Desvenlafaxine

Product NDC: 50090-4806
11-digit product format: 500904806
Labeler code: 50090
Product ID: 50090-4806_63c611a8-0cbe-4445-a075-65b6443166a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desvenlafaxine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA204082
Marketing category: ANDA
Marketing start: 2017-03-01
Substance: DESVENLAFAXINE SUCCINATE
Active strength: 50 mg/1
Pharmacologic classes: Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog.

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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A204082-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204082-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204082-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204082-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204082-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204082-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204082-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204082-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204082-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204082-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204082-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204082-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204082-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204082-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204082-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204082-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204082-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204082-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204082-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204082-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204082-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204082-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204082-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204082-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204082-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204082-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204082-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204082-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204082-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204082-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204082-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204082-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204082-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204082-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204082-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204082-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204082-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204082-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204082-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204082-002	AB	1	`5aa47cf7b7d7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Desvenlafaxine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESVENLAFAXINE SUCCINATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZB22ENF0XR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1874559	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
7107a864-fcb3-4cbf-9fcb-061bef13be2d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a9aae381-3b13-08a9-c49d-484a2c2a6dc8	Product name	7	20251106
99b326f2-4886-9fc8-8686-faef7b7f27dd	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4806-0	2023-02-06	C162847	48780-1	f386c649-e9cd-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
50090-4806-0	2023-01-30	C162847	48780-1	f386c649-e9cd-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4806-0	Desvenlafaxine	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		9
50090-4806-1	Desvenlafaxine	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4806-0	EA - Each	50090-4806	311eb933-32c0-4ae2-9dfe-b870d7691cd6	1	2024-08-12
50090-4806-1	EA - Each	50090-4806	272008d5-b444-4401-b8e8-1a0392a1bd0c	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4806	DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	9	Current NDC, Legacy NDC, 2 package rows	20241206_7107a864-fcb3-4cbf-9fcb-061bef13be2d.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	aca478a7-eff6-4cd5-93a8-2dca69883a4b	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204082 application number: ANDA204082
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	d585d916-2a5d-4baa-9c64-52b12313aba3	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204082 application number: ANDA204082
Desvenlafaxine	DESVENLAFAXINE	A-S Medication Solutions	7107a864-fcb3-4cbf-9fcb-061bef13be2d	2024-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204082 application number: ANDA204082 ndc (product): 50090-4806
Desvenlafaxine	DESVENLAFAXINE	American Health Packaging	e0dbbdbc-9438-407a-b3e1-f3bb7f177a4e	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204082 application number: ANDA204082

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZB22ENF0XR	DESVENLAFAXINE SUCCINATE	386750-22-7	DESVENLAFAXINE SUCCINATE
NG99554ANW	DESVENLAFAXINE	93413-62-8	Desvenlafaxine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	7107a864-fcb3-4cbf-9fcb-061bef13be2d	9
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	7107a864-fcb3-4cbf-9fcb-061bef13be2d	9
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	7107a864-fcb3-4cbf-9fcb-061bef13be2d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4806-0	50090480600	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4806-0)	2019-12-23	0000-00-00	No	No	Current
50090-4806-1	50090480601	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4806-1)	2024-11-26		No	No	Current