FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
70518-3195
11-digit product format
705183195
Labeler code
70518
Product ID
70518-3195_c9c5850d-3a37-25f5-e053-2995a90ab350
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210014
Marketing category
ANDA
Marketing start
2021-08-17
Marketing end
0000-00-00
Substance
DESVENLAFAXINE SUCCINATE
Active strength
25 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-3195DDiscontinued by firm2026-07-31
excluded packagepackage70518-319570518-3195-0DDiscontinued 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
A210014-001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01
A210014-002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01
A210014-003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210014-001AB
A210014-002AB
A210014-003AB

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 22:54:322026-06A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01a50c72e98297…
2026-08-01 22:54:322026-06A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01a50c72e98297…
2026-08-01 22:54:322026-06A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210014-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A210014-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A210014-003AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesvenlafaxineDESVENLAFAXINEBryant Ranch Prepack1d8889c9-9403-4b4b-8abd-7dc9a9fc18162026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210014
application number: ANDA210014
DesvenlafaxineDESVENLAFAXINEBryant Ranch Prepacka6c2316d-2a51-4975-a061-dc72f2724b2f2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210014
application number: ANDA210014
DesvenlafaxineDESVENLAFAXINEBryant Ranch Prepack6741bdef-dc58-47be-b28d-c43476dc8bde2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210014
application number: ANDA210014
DesvenlafaxineDESVENLAFAXINESlate Run Pharmaceuticals, LLC44f4b928-d5b8-44e7-bfa6-81fb0dc1a7182026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210014
application number: ANDA210014
DesvenlafaxineDESVENLAFAXINEA-S Medication Solutionsfd08efc0-6109-46ee-9556-f77b3f7b6baf2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210014
application number: ANDA210014

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3195-02023-03-22C16284748780-1f386c64a-2266-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
70518-3195-02023-01-30C16284748780-1f386c64a-2266-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3195-07051831950090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3195-0) 2021-08-170000-00-00NoNoCurrent