Desvenlafaxine

Product NDC
70518-2495
11-digit product format
705182495
Labeler code
70518
Product ID
70518-2495_9a06f003-899c-8373-e053-2995a90a1bc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204003
Marketing category
ANDA
Marketing start
2019-12-18
Marketing end
0000-00-00
Substance
DESVENLAFAXINE SUCCINATE
Active strength
50 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
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2495DDiscontinued by firm2026-08-07
excluded packagepackage70518-249570518-2495-0DDiscontinued by firm2026-08-07

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 · 24 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 packagepackage70518-2495-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2495-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2495-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2495-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2495-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2495-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2495-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2495-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2495-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2495-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2495-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2495-0557ba5c1ecfa…9c80585c8c6e…

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
A204003-001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29
A204003-002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29
A204003-003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204003-001AB
A204003-002AB
A204003-003AB

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 UTC2026-02A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-298072bd15b7f6…

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 UTC2026-02A204003-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204003-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204003-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204003-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204003-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204003-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204003-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204003-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204003-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204003-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204003-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204003-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204003-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204003-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204003-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204003-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204003-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204003-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204003-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204003-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204003-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204003-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204003-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204003-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204003-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204003-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204003-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204003-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204003-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204003-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204003-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204003-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204003-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204003-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204003-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204003-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204003-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204003-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204003-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204003-001AB18072bd15b7f6…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesvenlafaxineDESVENLAFAXINE SUCCINATEPreferred Pharmaceuticals Inc.b4a5efab-3765-4ea5-a8cd-66e67e76c8452026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
DesvenlafaxineDESVENLAFAXINE SUCCINATEPreferred Pharmaceutical, Inc.4b786ea1-309d-440c-b091-38d6b1f7fbd32026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
DesvenlafaxineDESVENLAFAXINE SUCCINATECoupler LLC325be002-4db2-40e9-e063-6394a90ae94e2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
desvenlafaxineDESVENLAFAXINE SUCCINATEDIRECT RXb3ef2bb2-c336-2d57-e053-2995a90a5fe02025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
DesvenlafaxineDESVENLAFAXINE SUCCINATEBryant Ranch Prepack5e78c812-7fe6-4a4e-8465-0415df2e98512024-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
DesvenlafaxineDESVENLAFAXINE SUCCINATEBryant Ranch Prepackf99c78ef-5a0a-45af-9b4b-5a78b75fe9942024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
DesvenlafaxineDESVENLAFAXINE SUCCINATEBryant Ranch Prepackc7c77c4d-dd04-4780-9fa4-8fea30aff8f92024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
DesvenlafaxineDESVENLAFAXINE SUCCINATEBreckenridge Pharmaceutical, Inc25bdfc41-c7cb-4d16-b6a8-f102f9b8c9842024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
DesvenlafaxineDESVENLAFAXINE SUCCINATEA-S Medication Solutions88ac1206-864b-47a3-82ab-be83bc9532f32023-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
DesvenlafaxineDESVENLAFAXINE SUCCINATEA-S Medication Solutionsb2a3edb8-ba64-4ead-b452-d6c8dbaba91d2023-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
DesvenlafaxineDESVENLAFAXINE SUCCINATEProficient Rx LPd4542c5e-f9e8-49c7-afa6-9dd4c4d485f22023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
DesvenlafaxineDESVENLAFAXINE SUCCINATEAlembic Pharmaceuticals Limited5bd203d2-477e-4d12-a875-cb8009f424102023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003