Desvenlafaxine

Product NDC
68788-7194
11-digit product format
687887194
Labeler code
68788
Product ID
68788-7194_a6d606dc-0f00-487f-8772-cd2d5f2efe7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceutical, Inc.
Application
ANDA204003
Marketing category
ANDA
Marketing start
2018-07-18
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

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
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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-14caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204003-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204003-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204003-003AB1caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Desvenlafaxine
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
4b786ea1-309d-440c-b091-38d6b1f7fbd3Available 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
68788-7194-1Desvenlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
68788-7194-3Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE309
68788-7194-6Desvenlafaxine60 in 1 BOTTLETABLET, EXTENDED RELEASE609
68788-7194-9Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7194-1EA - Each68788-71944f0cfdef-1bc8-4f00-8aea-87393dc3b32612018-09-05
68788-7194-3EA - Each68788-7194e7665b48-2640-4950-844d-440cf5a66ac112018-09-05
68788-7194-6EA - Each68788-719438cccbb1-4488-45cd-90ff-47ff800e91da12018-09-05
68788-7194-9EA - Each68788-71946768e727-f2a1-450e-93d2-8a862eeafc6b12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7194DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICAL, INC.]8Current NDC, Legacy NDC, 4 package rows20250315_4b786ea1-309d-440c-b091-38d6b1f7fbd3.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesvenlafaxineDESVENLAFAXINE SUCCINATEBreckenridge Pharmaceutical, Inc25bdfc41-c7cb-4d16-b6a8-f102f9b8c9842026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204003
application number: ANDA204003
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
ndc (product): 68788-7194
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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN4b786ea1-309d-440c-b091-38d6b1f7fbd39
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD4b786ea1-309d-440c-b091-38d6b1f7fbd39
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY4b786ea1-309d-440c-b091-38d6b1f7fbd39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7194-168788719401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-1) 2018-07-180000-00-00NoNoCurrent
68788-7194-36878871940330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-3) 2018-07-180000-00-00NoNoCurrent
68788-7194-66878871940660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-6) 2018-07-180000-00-00NoNoCurrent
68788-7194-96878871940990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-9) 2018-07-180000-00-00NoNoCurrent