Desvenlafaxine

Product NDC
60687-607
11-digit product format
606870607
Labeler code
60687
Product ID
60687-607_2423ba9f-e3f1-de11-e063-6294a90a64fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA204082
Marketing category
ANDA
Marketing start
2021-12-01
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-08-23 18:47 UTC2025-08A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-1687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A204082-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2016-02-165aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A204082-002DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2017-08-285aa47cf7b7d7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A204082-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204082-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204082-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204082-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204082-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204082-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204082-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204082-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204082-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204082-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204082-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204082-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204082-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204082-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204082-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204082-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204082-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204082-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204082-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204082-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204082-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204082-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204082-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204082-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204082-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204082-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204082-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204082-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204082-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204082-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204082-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204082-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204082-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204082-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204082-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204082-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204082-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204082-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204082-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A204082-002AB15aa47cf7b7d7…

Additional Listing Data#

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

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
e0dbbdbc-9438-407a-b3e1-f3bb7f177a4eAvailable 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
60687-607-11Desvenlafaxine1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE15
60687-607-21Desvenlafaxine30 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-607-11EA - Each60687-6073f5fc994-f4b1-4170-96a7-04695307c9c112021-11-09
60687-607-21EA - Each60687-6074882d43a-6c32-4c66-b54f-8fe7e0af9a4712021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-607DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20241013_e0dbbdbc-9438-407a-b3e1-f3bb7f177a4e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesvenlafaxineDESVENLAFAXINEBryant Ranch Prepackaca478a7-eff6-4cd5-93a8-2dca69883a4b2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204082
application number: ANDA204082
DesvenlafaxineDESVENLAFAXINEBryant Ranch Prepackd585d916-2a5d-4baa-9c64-52b12313aba32026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204082
application number: ANDA204082
DesvenlafaxineDESVENLAFAXINEA-S Medication Solutions7107a864-fcb3-4cbf-9fcb-061bef13be2d2024-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204082
application number: ANDA204082
DesvenlafaxineDESVENLAFAXINEAmerican Health Packaginge0dbbdbc-9438-407a-b3e1-f3bb7f177a4e2024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204082
application number: ANDA204082
ndc (product): 60687-607

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNe0dbbdbc-9438-407a-b3e1-f3bb7f177a4e5
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDe0dbbdbc-9438-407a-b3e1-f3bb7f177a4e5
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYe0dbbdbc-9438-407a-b3e1-f3bb7f177a4e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-607-11606870607111 in 1 BLISTER PACKHistorical
60687-607-216068706072130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-607-21) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (60687-607-11) 30 blister pack2021-12-010000-00-00NoNoCurrent