Desvenlafaxine

Product NDC: 63304-191
11-digit product format: 633040191
Labeler code: 63304
Product ID: 63304-191_cd04a0b2-a7f2-4629-997f-af2a8e65f15b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desvenlafaxine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA204150
Marketing category: NDA
Marketing start: 2013-03-05
Substance: DESVENLAFAXINE
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 · 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	50 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
91cf39c9-4d26-480a-a3a3-a3d8d4c4d222	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	Strength	SPL version
63304-191-30	Desvenlafaxine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		34
63304-191-90	Desvenlafaxine	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90		34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-191-30	EA - Each	63304-191	87a40623-90aa-4ad3-9bd1-eff2ef3fb317	1	2013-05-02
63304-191-90	EA - Each	63304-191	f4ba549b-15bc-4dfb-bf3e-bece26743b78	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DESVENLAFAXINE	ACTIVE INGREDIENT	NG99554ANW	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
DESVENLAFAXINE	ACTIVE MOIETY	NG99554ANW	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DESVENLAFAXINE TABLET, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-191	DESVENLAFAXINE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	34	Current NDC, Legacy NDC, 2 package rows	20230830_91cf39c9-4d26-480a-a3a3-a3d8d4c4d222.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 ndc (product): 63304-191
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

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	91cf39c9-4d26-480a-a3a3-a3d8d4c4d222	34
790288	desvenlafaxine 50 MG 24HR Extended Release Oral Tablet	PSN	91cf39c9-4d26-480a-a3a3-a3d8d4c4d222	34
790264	24 HR desvenlafaxine 100 MG Extended Release Oral Tablet	SCD	91cf39c9-4d26-480a-a3a3-a3d8d4c4d222	34
790288	24 HR desvenlafaxine 50 MG Extended Release Oral Tablet	SCD	91cf39c9-4d26-480a-a3a3-a3d8d4c4d222	34
790264	desvenlafaxine 100 MG 24 HR Extended Release Oral Tablet	SY	91cf39c9-4d26-480a-a3a3-a3d8d4c4d222	34
790288	desvenlafaxine 50 MG 24 HR Extended Release Oral Tablet	SY	91cf39c9-4d26-480a-a3a3-a3d8d4c4d222	34

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-191-30	63304019130	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-191-30)	2013-03-05	0000-00-00	No	No	Current
63304-191-90	63304019190	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-191-90)	2013-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desvenlafaxine	Sun Pharmaceutical Industries, Inc. \| Alembic Pharmaceuticals Limited	2023-08-07	Human Prescription Drug Label	34