Desvenlafaxine

Product NDC
0591-3659
11-digit product format
005913659
Labeler code
0591
Product ID
0591-3659_9ae096b1-2fff-4410-b1c5-799171a05d54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA204065
Marketing category
ANDA
Marketing start
2017-03-01
Marketing end
2027-01-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204065-001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29
A204065-002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29
A204065-003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204065-001AB
A204065-002AB
A204065-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204065-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204065-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204065-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2016-07-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204065-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204065-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204065-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204065-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204065-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204065-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204065-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204065-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204065-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204065-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204065-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204065-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204065-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204065-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204065-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204065-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204065-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204065-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204065-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204065-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204065-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204065-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204065-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204065-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204065-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204065-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204065-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204065-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204065-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204065-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204065-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204065-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204065-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204065-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204065-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204065-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204065-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204065-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204065-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204065-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Desvenlafaxine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZB22ENF0XRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1607617Internal RxNorm lookup
1874553Internal RxNorm lookup
1874559Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
617476f9-62d7-40ef-a1b1-c349d4ad706fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9aae381-3b13-08a9-c49d-484a2c2a6dc8Product name720251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3659-30Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE3027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3659-19EA - Each0591-3659ec3d953c-bbec-450e-9c86-bfe33990a73612017-04-05
0591-3659-30EA - Each0591-36597f586f9e-a4d3-4dae-8ed3-aca4bb23e46d12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3659DESVENLAFAXINE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]26Current NDC, Legacy NDC, 1 package rows20240524_617476f9-62d7-40ef-a1b1-c349d4ad706f.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesvenlafaxineDESVENLAFAXINEActavis Pharma, Inc.617476f9-62d7-40ef-a1b1-c349d4ad706f2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204065
application number: ANDA204065
ndc (product): 0591-3659

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN617476f9-62d7-40ef-a1b1-c349d4ad706f27
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN617476f9-62d7-40ef-a1b1-c349d4ad706f27
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN617476f9-62d7-40ef-a1b1-c349d4ad706f27
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD617476f9-62d7-40ef-a1b1-c349d4ad706f27
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD617476f9-62d7-40ef-a1b1-c349d4ad706f27
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD617476f9-62d7-40ef-a1b1-c349d4ad706f27
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY617476f9-62d7-40ef-a1b1-c349d4ad706f27
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY617476f9-62d7-40ef-a1b1-c349d4ad706f27
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY617476f9-62d7-40ef-a1b1-c349d4ad706f27
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNaa664284-6936-4733-a412-a8b137b887232
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDaa664284-6936-4733-a412-a8b137b887232
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYaa664284-6936-4733-a412-a8b137b887232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3659-300059136593030 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-3659-30) 2017-03-010000-00-00NoNoCurrent