Desvenlafaxine

Product NDC: 51991-311
11-digit product format: 519910311
Labeler code: 51991
Product ID: 51991-311_34b890a1-3d88-43fb-b54b-f168ae22ebc7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desvenlafaxine Succinate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc
Application: ANDA204003
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 · 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
A204003-001	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29
A204003-002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29
A204003-003	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204003-001	AB
A204003-002	AB
A204003-003	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 4 · 123 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	A204003-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204003-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204003-001	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	A204003-002	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	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204003-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204003-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204003-001	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	A204003-002	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	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204003-001	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	A204003-002	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	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204003-001	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	A204003-002	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	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204003-001	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	A204003-002	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	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204003-001	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	A204003-002	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	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204003-001	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	A204003-002	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	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204003-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204003-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204003-001	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	A204003-002	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	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204003-001	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	A204003-002	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	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204003-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204003-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204003-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204003-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A204003-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204003-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204003-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204003-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204003-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204003-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204003-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204003-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204003-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204003-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204003-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204003-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204003-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204003-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204003-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204003-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204003-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204003-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204003-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204003-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204003-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204003-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204003-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204003-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204003-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204003-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204003-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204003-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204003-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204003-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204003-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204003-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204003-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204003-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204003-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204003-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204003-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204003-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204003-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204003-001	AB	1	`8072bd15b7f6…`

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 · 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
25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	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
51991-311-01	Desvenlafaxine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	23
51991-311-10	Desvenlafaxine	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	23
51991-311-11	Desvenlafaxine	100 in 1 CARTON	TABLET, EXTENDED RELEASE	100	23
51991-311-14	Desvenlafaxine	14 in 1 BOTTLE	TABLET, EXTENDED RELEASE	14	23
51991-311-33	Desvenlafaxine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	23
51991-311-80	Desvenlafaxine	80 in 1 CARTON	TABLET, EXTENDED RELEASE	80	23
51991-311-90	Desvenlafaxine	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-311-10	EA - Each	51991-311	dc5064de-2ed6-4bf1-ad96-852cf88e76ad	1	2017-04-05
51991-311-33	EA - Each	51991-311	8794fb98-d26d-43eb-8b28-bc7064788405	1	2017-04-05
51991-311-90	EA - Each	51991-311	15a3537c-3453-41a0-9e00-61122a36c9d9	1	2017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DESVENLAFAXINE SUCCINATE	ACTIVE INGREDIENT	ZB22ENF0XR	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
DESVENLAFAXINE	ACTIVE MOIETY	NG99554ANW	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-311	DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]	23	Current NDC, Legacy NDC, 7 package rows	20241004_25bdfc41-c7cb-4d16-b6a8-f102f9b8c984.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Preferred Pharmaceuticals Inc.	b4a5efab-3765-4ea5-a8cd-66e67e76c845	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Preferred Pharmaceutical, Inc.	4b786ea1-309d-440c-b091-38d6b1f7fbd3	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Coupler LLC	325be002-4db2-40e9-e063-6394a90ae94e	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003
desvenlafaxine	DESVENLAFAXINE SUCCINATE	DIRECT RX	b3ef2bb2-c336-2d57-e053-2995a90a5fe0	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Bryant Ranch Prepack	5e78c812-7fe6-4a4e-8465-0415df2e9851	2024-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Bryant Ranch Prepack	f99c78ef-5a0a-45af-9b4b-5a78b75fe994	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Bryant Ranch Prepack	c7c77c4d-dd04-4780-9fa4-8fea30aff8f9	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Breckenridge Pharmaceutical, Inc	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003 ndc (product): 51991-311
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	A-S Medication Solutions	88ac1206-864b-47a3-82ab-be83bc9532f3	2023-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	A-S Medication Solutions	b2a3edb8-ba64-4ead-b452-d6c8dbaba91d	2023-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Proficient Rx LP	d4542c5e-f9e8-49c7-afa6-9dd4c4d485f2	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Alembic Pharmaceuticals Limited	5bd203d2-477e-4d12-a875-cb8009f42410	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204003 application number: ANDA204003

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	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	23
1607617	desvenlafaxine succinate 25 MG 24HR Extended Release Oral Tablet	PSN	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	23
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	23
1874553	24 HR desvenlafaxine succinate 100 MG Extended Release Oral Tablet	SCD	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	23
1607617	24 HR desvenlafaxine succinate 25 MG Extended Release Oral Tablet	SCD	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	23
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	23
1874553	desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral Tablet	SY	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	23
1607617	desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral Tablet	SY	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	23
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	23
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	f99c78ef-5a0a-45af-9b4b-5a78b75fe994	16
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	f99c78ef-5a0a-45af-9b4b-5a78b75fe994	16
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	f99c78ef-5a0a-45af-9b4b-5a78b75fe994	16
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	4b786ea1-309d-440c-b091-38d6b1f7fbd3	9
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	4b786ea1-309d-440c-b091-38d6b1f7fbd3	9
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	4b786ea1-309d-440c-b091-38d6b1f7fbd3	9
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	88ac1206-864b-47a3-82ab-be83bc9532f3	6
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	88ac1206-864b-47a3-82ab-be83bc9532f3	6
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	88ac1206-864b-47a3-82ab-be83bc9532f3	6
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	b3ef2bb2-c336-2d57-e053-2995a90a5fe0	3
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	b3ef2bb2-c336-2d57-e053-2995a90a5fe0	3
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	b3ef2bb2-c336-2d57-e053-2995a90a5fe0	3
1874559	desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet	PSN	df60a82e-0d1e-6cc8-e053-2995a90a9ba4	1
1874559	24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet	SCD	df60a82e-0d1e-6cc8-e053-2995a90a9ba4	1
1874559	desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet	SY	df60a82e-0d1e-6cc8-e053-2995a90a9ba4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-311-01	51991031101	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-311-01)	2017-03-01	0000-00-00	No	No	Current
51991-311-10	51991031110	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-311-10)	2017-03-01	0000-00-00	No	No	Current
51991-311-11	51991031111	100 TABLET, EXTENDED RELEASE in 1 CARTON (51991-311-11)	2017-03-01	0000-00-00	No	No	Current
51991-311-14	51991031114	14 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-311-14)	2017-03-01	0000-00-00	No	No	Current
51991-311-33	51991031133	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-311-33)	2017-03-01	0000-00-00	No	No	Current
51991-311-80	51991031180	80 TABLET, EXTENDED RELEASE in 1 CARTON (51991-311-80)	2017-03-01	0000-00-00	No	No	Current
51991-311-90	51991031190	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-311-90)	2017-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desvenlafaxine	Preferred Pharmaceutical, Inc.	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	9
DESVENLAFAXINE	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	3
Desvenlafaxine	Bryant Ranch Prepack	2024-10-29	HUMAN PRESCRIPTION DRUG LABEL	16
Desvenlafaxine	Breckenridge Pharmaceutical, Inc \| Alembic Pharmaceuticals Limited	2024-08-22	Human Prescription Drug Label	23
Desvenlafaxine	A-S Medication Solutions	2023-09-19	Human Prescription Drug Label	6
Desvenlafaxine	NuCare Pharmaceuticals,Inc.	2022-05-19	HUMAN PRESCRIPTION DRUG LABEL	1
Desvenlafaxine	REMEDYREPACK INC.	2019-12-18	HUMAN PRESCRIPTION DRUG LABEL	1