Desvenlafaxine

Product NDC
71335-1753
11-digit product format
713351753
Labeler code
71335
Product ID
71335-1753_3dd007f9-261b-47e8-8dfc-d92ffdd2f430
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210014
Marketing category
ANDA
Marketing start
2020-08-01
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
2027-12-31
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
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.

Product history page 1 of 3 · 118 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210014-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210014-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210014-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2018-10-018072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 110 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210014-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210014-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210014-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210014-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210014-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210014-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210014-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210014-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210014-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210014-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210014-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210014-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210014-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210014-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210014-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210014-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210014-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210014-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210014-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210014-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210014-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210014-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210014-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210014-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210014-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210014-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210014-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210014-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210014-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210014-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210014-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210014-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210014-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210014-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210014-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210014-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210014-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210014-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210014-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210014-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Desvenlafaxine
Listing expiration
2027-12-31

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
a6c2316d-2a51-4975-a061-dc72f2724b2fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9aae381-3b13-08a9-c49d-484a2c2a6dc8Product name720251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1753-1Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE30106
71335-1753-2Desvenlafaxine28 in 1 BOTTLETABLET, EXTENDED RELEASE28106
71335-1753-3Desvenlafaxine60 in 1 BOTTLETABLET, EXTENDED RELEASE60106
71335-1753-4Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE90106
71335-1753-5Desvenlafaxine180 in 1 BOTTLETABLET, EXTENDED RELEASE180106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1753DESVENLAFAXINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 5 package rows20240727_a6c2316d-2a51-4975-a061-dc72f2724b2f.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 · 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
ndc (product): 71335-1753
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNa6c2316d-2a51-4975-a061-dc72f2724b2f106
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDa6c2316d-2a51-4975-a061-dc72f2724b2f106
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYa6c2316d-2a51-4975-a061-dc72f2724b2f106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1753-17133517530130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1753-1) 2021-01-120000-00-00NoNoCurrent
71335-1753-27133517530228 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1753-2) 2024-07-170000-00-00NoNoCurrent
71335-1753-37133517530360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1753-3) 2024-07-170000-00-00NoNoCurrent
71335-1753-47133517530490 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1753-4) 2021-08-250000-00-00NoNoCurrent
71335-1753-571335175305180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1753-5) 2024-07-17NoNoCurrent