FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
51991-312
11-digit product format
519910312
Labeler code
51991
Product ID
51991-312_34b890a1-3d88-43fb-b54b-f168ae22ebc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc
Application
ANDA204003
Marketing category
ANDA
Marketing start
2017-03-01
Substance
DESVENLAFAXINE SUCCINATE
Active strength
100 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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204003-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29a50c72e98297…
2026-08-01 22:54:322026-06A204003-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29a50c72e98297…
2026-08-01 22:54:322026-06A204003-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204003-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204003-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A204003-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 51991-312
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

Additional Listing Data#

Finished product
Yes
Brand name base
Desvenlafaxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE100 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
25bdfc41-c7cb-4d16-b6a8-f102f9b8c984Available 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
51991-312-01Desvenlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE10023
51991-312-10Desvenlafaxine1000 in 1 BOTTLETABLET, EXTENDED RELEASE100023
51991-312-11Desvenlafaxine100 in 1 CARTONTABLET, EXTENDED RELEASE10023
51991-312-14Desvenlafaxine14 in 1 BOTTLETABLET, EXTENDED RELEASE1423
51991-312-33Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE3023
51991-312-80Desvenlafaxine80 in 1 CARTONTABLET, EXTENDED RELEASE8023
51991-312-90Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-312-10EA - Each51991-312b768ed01-13e7-4410-b252-f222f5e092ca12017-04-05
51991-312-33EA - Each51991-3128ec7f036-5ee2-4361-9cc0-c42bd61b201712017-04-05
51991-312-90EA - Each51991-312ba5159f2-77ca-435a-b315-44b6c92b161612017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESVENLAFAXINE SUCCINATEACTIVE INGREDIENTZB22ENF0XRDESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
DESVENLAFAXINEACTIVE MOIETYNG99554ANWDESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZDESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-312DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC]23Current NDC, Legacy NDC, 7 package rows20241004_25bdfc41-c7cb-4d16-b6a8-f102f9b8c984.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSNc7c77c4d-dd04-4780-9fa4-8fea30aff8f9103
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCDc7c77c4d-dd04-4780-9fa4-8fea30aff8f9103
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSYc7c77c4d-dd04-4780-9fa4-8fea30aff8f9103
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN25bdfc41-c7cb-4d16-b6a8-f102f9b8c98423
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN25bdfc41-c7cb-4d16-b6a8-f102f9b8c98423
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN25bdfc41-c7cb-4d16-b6a8-f102f9b8c98423
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD25bdfc41-c7cb-4d16-b6a8-f102f9b8c98423
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD25bdfc41-c7cb-4d16-b6a8-f102f9b8c98423
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD25bdfc41-c7cb-4d16-b6a8-f102f9b8c98423
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY25bdfc41-c7cb-4d16-b6a8-f102f9b8c98423
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY25bdfc41-c7cb-4d16-b6a8-f102f9b8c98423
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY25bdfc41-c7cb-4d16-b6a8-f102f9b8c98423
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSNb4a5efab-3765-4ea5-a8cd-66e67e76c84510
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCDb4a5efab-3765-4ea5-a8cd-66e67e76c84510
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSYb4a5efab-3765-4ea5-a8cd-66e67e76c84510
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSNd4542c5e-f9e8-49c7-afa6-9dd4c4d485f22
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCDd4542c5e-f9e8-49c7-afa6-9dd4c4d485f22
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSYd4542c5e-f9e8-49c7-afa6-9dd4c4d485f22
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN325be002-4db2-40e9-e063-6394a90ae94e1
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD325be002-4db2-40e9-e063-6394a90ae94e1
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY325be002-4db2-40e9-e063-6394a90ae94e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-312-0151991031201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-01) 2017-03-010000-00-00NoNoCurrent
51991-312-10519910312101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-10) 2017-03-010000-00-00NoNoCurrent
51991-312-1151991031211100 TABLET, EXTENDED RELEASE in 1 CARTON (51991-312-11) 2017-03-010000-00-00NoNoCurrent
51991-312-145199103121414 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-14) 2017-03-010000-00-00NoNoCurrent
51991-312-335199103123330 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-33) 2017-03-010000-00-00NoNoCurrent
51991-312-805199103128080 TABLET, EXTENDED RELEASE in 1 CARTON (51991-312-80) 2017-03-010000-00-00NoNoCurrent
51991-312-905199103129090 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-90) 2017-03-010000-00-00NoNoCurrent