FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
46708-152
Requested package NDC
46708-152-90
11-digit product format
467080152
Labeler code
46708
Product ID
46708-152_6ebe192e-2b88-43fc-a2c8-db2c42bc5a43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
NDA204150
Marketing category
NDA
Marketing start
2013-03-05
Substance
DESVENLAFAXINE
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204150-001DESVENLAFAXINEDESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-04
N204150-002DESVENLAFAXINEDESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-04

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-0484e616aacf4f…
2026-09-14 22:38:342026-08N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-0484e616aacf4f…
2026-08-18 06:07:402026-07N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD2013-03-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204150-001DESVENLAFAXINE50MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204150-002DESVENLAFAXINE100MGTABLET, EXTENDED RELEASE / ORALRLD, RS2013-03-0474a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NG99554ANWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
790264Internal RxNorm lookup
790288Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f74708c-6f6a-46cf-8c79-87a25c2bb6f8Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
46708-152-302023-02-01These highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
46708-152-902023-02-01These highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
46708-152-302023-01-30These highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
46708-152-902023-01-30These highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-152-30Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
46708-152-90Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-152DESVENLAFAXINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 2 package rows20230202_9f74708c-6f6a-46cf-8c79-87a25c2bb6f8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesvenlafaxineDESVENLAFAXINESun Pharmaceutical Industries, Inc.91cf39c9-4d26-480a-a3a3-a3d8d4c4d2222023-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 204150
application number: NDA204150
DesvenlafaxineDESVENLAFAXINEAlembic Pharmaceuticals Limited9f74708c-6f6a-46cf-8c79-87a25c2bb6f82023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 204150
application number: NDA204150
ndc (package): 46708-152-90
ndc (product): 46708-152
ndc11 (package): 46708015290

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
790264desvenlafaxine 100 MG 24HR Extended Release Oral TabletPSN9f74708c-6f6a-46cf-8c79-87a25c2bb6f82
790288desvenlafaxine 50 MG 24HR Extended Release Oral TabletPSN9f74708c-6f6a-46cf-8c79-87a25c2bb6f82
79026424 HR desvenlafaxine 100 MG Extended Release Oral TabletSCD9f74708c-6f6a-46cf-8c79-87a25c2bb6f82
79028824 HR desvenlafaxine 50 MG Extended Release Oral TabletSCD9f74708c-6f6a-46cf-8c79-87a25c2bb6f82
790264desvenlafaxine 100 MG 24 HR Extended Release Oral TabletSY9f74708c-6f6a-46cf-8c79-87a25c2bb6f82
790288desvenlafaxine 50 MG 24 HR Extended Release Oral TabletSY9f74708c-6f6a-46cf-8c79-87a25c2bb6f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-152-904670801529090 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-152-90) 2013-03-050000-00-00NoNoCurrent