Desvenlafaxine Succinate

Product NDC
68788-7488
Requested package NDC
68788-7488-9
11-digit product format
687887488
Labeler code
68788
Product ID
68788-7488_ef9c2990-b917-413b-a994-51643ead21c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204172
Marketing category
ANDA
Marketing start
2020-04-30
Marketing end
0000-00-00
Substance
DESVENLAFAXINE SUCCINATE
Active strength
100 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-748868788-7488-9DDiscontinued by firm2026-09-14

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2984e616aacf4f…
2026-09-14 22:38:342026-08A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2984e616aacf4f…
2026-09-14 22:38:342026-08A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-1384e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A204172-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A204172-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A204172-003AB184e616aacf4f…
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…

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7488-96878874880990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7488-9) 2020-04-300000-00-00NoNoCurrent