FDA.reportPublic FDA data

Desvenlafaxine Succinate

Product NDC
68788-7448
Requested package NDC
68788-7448-3
11-digit product format
687887448
Labeler code
68788
Product ID
68788-7448_bf07c6ab-cf54-4c0c-a079-91090eec12af
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
2019-08-20
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-744868788-7448-3DDiscontinued by firm2026-07-31

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204172-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29a50c72e98297…
2026-08-01 22:54:322026-06A204172-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29a50c72e98297…
2026-08-01 22:54:322026-06A204172-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-04-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204172-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204172-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A204172-003AB1a50c72e98297…

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 · 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7448-1EA - Each68788-7448b219c0fd-196e-432b-94e2-fa9b47367a8712020-09-14
68788-7448-3EA - Each68788-7448ee543e79-e2b0-4db2-b267-3e5e0d8f8ad812020-09-14
68788-7448-6EA - Each68788-74485f89bcfa-a7e0-459c-a42b-f29085601a9212020-09-14
68788-7448-9EA - Each68788-7448260d78b9-e1b8-49e6-8130-91dae0af033e12020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7448-36878874480330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7448-3) 2019-08-200000-00-00NoNoCurrent