Desvenlafaxine Succinate

Product NDC: 68180-592
11-digit product format: 681800592
Labeler code: 68180
Product ID: 68180-592_748a4941-405f-436f-933b-0bec4b119e3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desvenlafaxine Succinate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA204172
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68180-592	68180-592-09	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204172-001	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29
A204172-002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29
A204172-003	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204172-001	AB
A204172-002	AB
A204172-003	AB

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 3 · 114 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
2026-08-18 06:07:40	2026-07	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204172-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204172-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204172-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204172-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204172-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204172-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204172-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204172-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204172-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204172-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204172-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204172-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204172-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204172-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204172-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204172-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204172-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204172-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204172-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204172-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204172-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204172-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204172-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204172-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204172-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204172-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204172-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204172-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204172-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204172-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204172-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204172-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204172-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204172-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204172-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204172-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204172-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204172-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204172-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204172-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204172-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204172-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204172-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Desvenlafaxine Succinate
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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1607617	Internal RxNorm lookup
1874553	Internal RxNorm lookup
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
e96272a2-8f73-4fbe-a8d4-a78d4ad68831	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
99b326f2-4886-9fc8-8686-faef7b7f27dd	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68180-592-02	Desvenlafaxine Succinate	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	23
68180-592-06	Desvenlafaxine Succinate	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	23
68180-592-09	Desvenlafaxine Succinate	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-592-06	EA - Each	68180-592	cfb2aae7-d2c3-4935-a576-fd128d62e2d1	1	2017-04-05
68180-592-09	EA - Each	68180-592	f826a628-d7ed-49e0-8a42-fd91782f0b70	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-592	DESVENLAFAXINE SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	22	Current NDC, Legacy NDC, 3 package rows	20250510_e96272a2-8f73-4fbe-a8d4-a78d4ad68831.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Bryant Ranch Prepack	56c9e8ee-1460-4a4c-8033-65d9afb358c8	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204172 application number: ANDA204172
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Bryant Ranch Prepack	593d340b-f49a-455b-aeb2-5a1eaf7b6cbe	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204172 application number: ANDA204172
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	A-S Medication Solutions	5755f1b2-c10b-47f6-a08d-38d1c05bd353	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204172 application number: ANDA204172
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Bryant Ranch Prepack	5f349cc5-b803-462d-b323-d681bd1a02f0	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204172 application number: ANDA204172
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Preferred Pharmaceuticals Inc.	453a5759-2f0d-421d-be78-81ab97c8ce77	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204172 application number: ANDA204172
DESVENLAFAXINE ER	DESVENLAFAXINE ER	Direct_Rx	8a834c66-846e-38a8-e053-2a95a90a4035	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204172 application number: ANDA204172
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Lupin Pharmaceuticals, Inc.	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204172 application number: ANDA204172 ndc (product): 68180-592
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	A-S Medication Solutions	7ee04e8c-ce6c-450d-9122-2bffd170bfd7	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204172 application number: ANDA204172

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZB22ENF0XR	DESVENLAFAXINE SUCCINATE	386750-22-7	DESVENLAFAXINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1874553	desvenlafaxine succinate 100 MG 24HR Extended Release Oral Tablet	PSN	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	23
1607617	desvenlafaxine succinate 25 MG 24HR Extended Release Oral Tablet	PSN	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	23
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	23
1874553	24 HR desvenlafaxine succinate 100 MG Extended Release Oral Tablet	SCD	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	23
1607617	24 HR desvenlafaxine succinate 25 MG Extended Release Oral Tablet	SCD	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	23
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	23
1874553	desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral Tablet	SY	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	23
1607617	desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral Tablet	SY	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	23
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	23
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	593d340b-f49a-455b-aeb2-5a1eaf7b6cbe	9
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	593d340b-f49a-455b-aeb2-5a1eaf7b6cbe	9
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	593d340b-f49a-455b-aeb2-5a1eaf7b6cbe	9
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	5755f1b2-c10b-47f6-a08d-38d1c05bd353	4
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	5755f1b2-c10b-47f6-a08d-38d1c05bd353	4
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	5755f1b2-c10b-47f6-a08d-38d1c05bd353	4
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	8a834c66-846e-38a8-e053-2a95a90a4035	3
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	8a834c66-846e-38a8-e053-2a95a90a4035	3
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	8a834c66-846e-38a8-e053-2a95a90a4035	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-592-02	68180059202	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-592-02)	2017-03-01	0000-00-00	No	No	Current
68180-592-06	68180059206	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-592-06)	2017-03-01	0000-00-00	No	No	Current
68180-592-09	68180059209	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-592-09)	2017-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desvenlafaxine Succinate	Bryant Ranch Prepack	2026-06-05	HUMAN PRESCRIPTION DRUG LABEL	10
Desvenlafaxine Succinate	A-S Medication Solutions	2026-05-08	HUMAN PRESCRIPTION DRUG LABEL	4
DESVENLAFAXINE ER	Direct_Rx	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	3
Desvenlafaxine Succinate	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-12-29	HUMAN PRESCRIPTION DRUG LABEL	23
Desvenlafaxine Succinate	Preferred Pharmaceuticals Inc.	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	3