Desvenlafaxine

Product NDC: 46708-153
11-digit product format: 467080153
Labeler code: 46708
Product ID: 46708-153_6ebe192e-2b88-43fc-a2c8-db2c42bc5a43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desvenlafaxine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: NDA204150
Marketing category: NDA
Marketing start: 2013-03-05
Substance: DESVENLAFAXINE
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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204150-001	DESVENLAFAXINE	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2013-03-04
N204150-002	DESVENLAFAXINE	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2013-03-04

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 · 82 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	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESVENLAFAXINE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NG99554ANW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
790264	Internal RxNorm lookup
790288	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
9f74708c-6f6a-46cf-8c79-87a25c2bb6f8	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, Related label table
NDC	Effective	Related label
46708-153-30	2023-02-01	These highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
46708-153-90	2023-02-01	These highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
46708-153-30	2023-01-30	These highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
46708-153-90	2023-01-30	These highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. 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
46708-153-30	Desvenlafaxine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		2
46708-153-90	Desvenlafaxine	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-153	DESVENLAFAXINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20230202_9f74708c-6f6a-46cf-8c79-87a25c2bb6f8.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
Desvenlafaxine	DESVENLAFAXINE	Sun Pharmaceutical Industries, Inc.	91cf39c9-4d26-480a-a3a3-a3d8d4c4d222	2023-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204150 application number: NDA204150
Desvenlafaxine	DESVENLAFAXINE	Alembic Pharmaceuticals Limited	9f74708c-6f6a-46cf-8c79-87a25c2bb6f8	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204150 application number: NDA204150 ndc (product): 46708-153

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NG99554ANW	DESVENLAFAXINE	93413-62-8	DESVENLAFAXINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
790264	desvenlafaxine 100 MG 24HR Extended Release Oral Tablet	PSN	9f74708c-6f6a-46cf-8c79-87a25c2bb6f8	2
790288	desvenlafaxine 50 MG 24HR Extended Release Oral Tablet	PSN	9f74708c-6f6a-46cf-8c79-87a25c2bb6f8	2
790264	24 HR desvenlafaxine 100 MG Extended Release Oral Tablet	SCD	9f74708c-6f6a-46cf-8c79-87a25c2bb6f8	2
790288	24 HR desvenlafaxine 50 MG Extended Release Oral Tablet	SCD	9f74708c-6f6a-46cf-8c79-87a25c2bb6f8	2
790264	desvenlafaxine 100 MG 24 HR Extended Release Oral Tablet	SY	9f74708c-6f6a-46cf-8c79-87a25c2bb6f8	2
790288	desvenlafaxine 50 MG 24 HR Extended Release Oral Tablet	SY	9f74708c-6f6a-46cf-8c79-87a25c2bb6f8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-153-30	46708015330	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-153-30)	2013-03-05	0000-00-00	No	No	Current
46708-153-90	46708015390	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-153-90)	2013-03-05	0000-00-00	No	No	Current