Desvenlafaxine Succinate

Product NDC
50090-6894
11-digit product format
500906894
Labeler code
50090
Product ID
50090-6894_3d224100-79ea-4a95-b679-4c950017faf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204172
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
2027-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-6894-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-6894-0f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204172-001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29
A204172-002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29
A204172-003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204172-001AB
A204172-002AB
A204172-003AB

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 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-291e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204172-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204172-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204172-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204172-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204172-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204172-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204172-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204172-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204172-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204172-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204172-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204172-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204172-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204172-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204172-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204172-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204172-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204172-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204172-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204172-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204172-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204172-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Desvenlafaxine Succinate
Listing expiration
2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
5755f1b2-c10b-47f6-a08d-38d1c05bd353Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9aae381-3b13-08a9-c49d-484a2c2a6dc8Product name720251106
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6894-0Desvenlafaxine Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6894-0EA - Each50090-68942fec9bb3-69ec-478f-9756-8d7e162bfdf312024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6894DESVENLAFAXINE SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20231216_5755f1b2-c10b-47f6-a08d-38d1c05bd353.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEBryant Ranch Prepack56c9e8ee-1460-4a4c-8033-65d9afb358c82026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEBryant Ranch Prepack593d340b-f49a-455b-aeb2-5a1eaf7b6cbe2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEA-S Medication Solutions5755f1b2-c10b-47f6-a08d-38d1c05bd3532026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
ndc (product): 50090-6894
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEBryant Ranch Prepack5f349cc5-b803-462d-b323-d681bd1a02f02026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEPreferred Pharmaceuticals Inc.453a5759-2f0d-421d-be78-81ab97c8ce772026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
DESVENLAFAXINE ERDESVENLAFAXINE ERDirect_Rx8a834c66-846e-38a8-e053-2a95a90a40352026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATELupin Pharmaceuticals, Inc.e96272a2-8f73-4fbe-a8d4-a78d4ad688312025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEA-S Medication Solutions7ee04e8c-ce6c-450d-9122-2bffd170bfd72024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204172
application number: ANDA204172

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN5755f1b2-c10b-47f6-a08d-38d1c05bd3534
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD5755f1b2-c10b-47f6-a08d-38d1c05bd3534
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY5755f1b2-c10b-47f6-a08d-38d1c05bd3534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6894-05009068940030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-6894-0) 2023-12-07NoNoCurrent