Desvenlafaxine ER

Product NDC
72189-567
11-digit product format
721890567
Labeler code
72189
Product ID
72189-567_34f5586c-4441-54fb-e063-6394a90aa90d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine ER
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_rx
Application
ANDA204028
Marketing category
ANDA
Marketing start
2024-07-18
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 · source snapshot 42.

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
A204028-001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29
A204028-002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29
A204028-003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204028-001AB
A204028-002AB
A204028-003AB

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 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204028-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204028-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2023-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204028-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-291e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204028-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204028-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204028-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204028-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204028-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204028-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204028-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204028-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204028-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204028-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204028-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204028-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204028-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204028-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204028-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204028-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204028-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204028-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204028-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204028-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204028-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204028-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204028-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204028-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204028-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204028-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204028-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204028-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204028-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204028-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204028-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204028-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204028-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204028-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204028-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204028-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204028-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204028-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204028-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204028-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Desvenlafaxine ER
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
1d86d1dc-d685-43aa-e063-6294a90a9907Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9aae381-3b13-08a9-c49d-484a2c2a6dc8Product name720251106
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-567-28Desvenlafaxine ER28 in 1 BOTTLETABLET, EXTENDED RELEASE283
72189-567-30Desvenlafaxine ER30 in 1 BOTTLETABLET, EXTENDED RELEASE303
72189-567-60Desvenlafaxine ER60 in 1 BOTTLETABLET, EXTENDED RELEASE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-567-28EA - Each72189-56778e19cd0-89d2-4ecc-9471-15d42a927ad312024-10-04
72189-567-30EA - Each72189-56776afa022-64d7-45e3-887f-c59e00baa42712025-06-13
72189-567-60EA - Each72189-56774adde61-6b3a-453c-82e9-706e3d7c02ef12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-567DESVENLAFAXINE ER TABLET, EXTENDED RELEASE [DIRECT_RX]3Current NDC, 3 package rows20250514_1d86d1dc-d685-43aa-e063-6294a90a9907.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DESVENLAFAXINEDESVENLAFAXINEBryant Ranch Prepack65f4a870-aa91-4d05-a32d-a161295bcc172026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204028
application number: ANDA204028
DESVENLAFAXINEDESVENLAFAXINEBryant Ranch Prepack643bfe62-7885-4db4-9fff-5d8552b53d142026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204028
application number: ANDA204028
DESVENLAFAXINEDESVENLAFAXINEPreferred Pharmaceuticals Inc.5a136b61-f734-43d5-86fc-059ff3b5342a2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204028
application number: ANDA204028
DESVENLAFAXINEDESVENLAFAXINEAdvagen Pharma Ltdff837eb1-24c3-4c63-9b4b-c6b5935a9b472026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204028
application number: ANDA204028
DESVENLAFAXINEDESVENLAFAXINEA-S Medication Solutions48d3a09e-850d-472d-8fb2-996a5167b16d2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204028
application number: ANDA204028
DESVENLAFAXINEDESVENLAFAXINEA-S Medication Solutionsb14695b4-c35e-4902-8144-d31d698b1c582025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204028
application number: ANDA204028
Desvenlafaxine ERDESVENLAFAXINE ERDirect_rx1d86d1dc-d685-43aa-e063-6294a90a99072025-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204028
application number: ANDA204028
ndc (product): 72189-567
DESVENLAFAXINEDESVENLAFAXINENorthStar Rx LLC3fcc0555-f9cf-4735-a0ef-830c50c390b82025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204028
application number: ANDA204028
DESVENLAFAXINEDESVENLAFAXINENuCare Pharmaceuticals,Inc.2dce1542-ead5-1b24-e063-6294a90a6df02025-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204028
application number: ANDA204028
DESVENLAFAXINEDESVENLAFAXINEBryant Ranch Prepack5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a42025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204028
application number: ANDA204028

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN1d86d1dc-d685-43aa-e063-6294a90a99073
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD1d86d1dc-d685-43aa-e063-6294a90a99073
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY1d86d1dc-d685-43aa-e063-6294a90a99073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-567-287218905672828 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-567-28) 2024-07-18NoNoCurrent
72189-567-307218905673030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-567-30) 2024-07-18NoNoCurrent
72189-567-607218905676060 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-567-60) 2024-07-18NoNoCurrent