Desvenlafaxine

Product NDC: 0054-0401
11-digit product format: 000540401
Labeler code: 0054
Product ID: 0054-0401_c5148154-683f-4369-bb65-9f6f43a64e2b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desvenlafaxine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA204083
Marketing category: ANDA
Marketing start: 2017-03-01
Substance: DESVENLAFAXINE SUCCINATE
Active strength: 100 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0054-0401	0054-0401-06	D	Discontinued by firm		2026-08-11
excluded package	package	0054-0401	0054-0401-20	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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0054-0401-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0054-0401-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0054-0401-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0054-0401-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0054-0401-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0054-0401-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0054-0401-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0054-0401-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0054-0401-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0054-0401-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0054-0401-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0054-0401-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0054-0401-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0054-0401-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0054-0401-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0054-0401-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0054-0401-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0054-0401-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0054-0401-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0054-0401-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0054-0401-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0054-0401-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0054-0401-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0054-0401-06	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A204083-001	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16
A204083-002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16
A204083-003	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204083-001	AB
A204083-002	AB
A204083-003	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 2 · 47 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
2026-02-19 14:30 UTC	2026-02	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204083-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204083-003	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204083-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204083-003	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204083-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204083-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204083-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204083-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204083-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204083-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204083-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204083-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204083-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204083-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204083-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204083-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204083-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204083-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204083-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204083-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204083-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204083-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204083-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204083-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204083-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204083-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204083-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204083-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204083-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204083-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204083-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204083-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204083-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204083-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204083-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204083-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204083-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204083-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204083-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204083-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204083-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204083-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204083-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204083-001	AB	1	`3bdfa0b2c4d7…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESVENLAFAXINE SUCCINATE	100 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
662890ff-d254-40e0-a9fe-f07ab94d65d6	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0054-0401-06	Desvenlafaxine	14 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	14	11
0054-0401-13	Desvenlafaxine	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	11
0054-0401-20	Desvenlafaxine	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10	11
0054-0401-20	Desvenlafaxine	10 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	10	11
0054-0401-22	Desvenlafaxine	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0401-13	EA - Each	0054-0401	29a6dd19-e4ba-4a22-a335-5c8cb274bbd7	1	2017-04-05
0054-0401-22	EA - Each	0054-0401	41b90446-8726-4c21-8292-58f9a4ea980e	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0401	DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE [HIKMA PHARMACEUTICALS USA INC.]	10	Current NDC, Legacy NDC, 5 package rows	20241212_662890ff-d254-40e0-a9fe-f07ab94d65d6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desvenlafaxine	DESVENLAFAXINE	Hikma Pharmaceuticals USA Inc.	662890ff-d254-40e0-a9fe-f07ab94d65d6	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204083 application number: ANDA204083 ndc (product): 0054-0401

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
1874553	desvenlafaxine succinate 100 MG 24HR Extended Release Oral Tablet	PSN	662890ff-d254-40e0-a9fe-f07ab94d65d6	11
1607617	desvenlafaxine succinate 25 MG 24HR Extended Release Oral Tablet	PSN	662890ff-d254-40e0-a9fe-f07ab94d65d6	11
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	662890ff-d254-40e0-a9fe-f07ab94d65d6	11
1874553	24 HR desvenlafaxine succinate 100 MG Extended Release Oral Tablet	SCD	662890ff-d254-40e0-a9fe-f07ab94d65d6	11
1607617	24 HR desvenlafaxine succinate 25 MG Extended Release Oral Tablet	SCD	662890ff-d254-40e0-a9fe-f07ab94d65d6	11
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	662890ff-d254-40e0-a9fe-f07ab94d65d6	11
1874553	desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral Tablet	SY	662890ff-d254-40e0-a9fe-f07ab94d65d6	11
1607617	desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral Tablet	SY	662890ff-d254-40e0-a9fe-f07ab94d65d6	11
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	662890ff-d254-40e0-a9fe-f07ab94d65d6	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0401-06	00054040106	14 in 1 BOTTLE					Historical
0054-0401-13	00054040113	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-13)	2017-03-01	0000-00-00	No	No	Current
0054-0401-20	00054040120	10 in 1 BLISTER PACK					Historical
0054-0401-22	00054040122	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-22)	2017-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desvenlafaxine	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	11