DESVENLAFAXINE EXTENDED-RELEASE TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-26
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:48:26

Label at a glance#

ProductDesvenlafaxine
Active ingredientDESVENLAFAXINE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Desvenlafaxine Extended-release Tablets, 25 mg

NDC 70771-1661-3

30 tablets

Rx only

25 mg
25 mg

NDC 68382-469-67 in bottle of 14 tablets in unit-of-use package

Desvenlafaxine Extended-release Tablets, 50 mg

14 tablets

Rx  only

Zydus

Desvenlafaxine tablets
Desvenlafaxine tablets

NDC 68382-741-67 in bottle of 14 tablets in unit-of-use package

Desvenlafaxine Extended-release Tablets, 100 mg

14 tablets

Rx  only

Zydus

Desvenlafaxine tablets
Desvenlafaxine tablets

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

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
A204020-001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11
A204020-002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11
A204020-003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204020-001AB
A204020-002AB
A204020-003AB

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 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-1184e616aacf4f…
2026-09-14 22:38:342026-08A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-1184e616aacf4f…
2026-09-14 22:38:342026-08A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-3084e616aacf4f…
2026-08-18 06:07:402026-07A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11caaa826d4ba7…
2026-08-18 06:07:402026-07A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204020-002DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204020-003DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204020-001DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-10-11301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A204020-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A204020-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A204020-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A204020-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204020-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204020-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204020-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204020-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204020-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204020-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204020-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204020-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204020-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204020-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204020-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204020-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204020-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204020-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204020-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204020-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204020-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204020-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204020-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204020-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204020-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204020-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204020-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204020-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204020-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204020-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204020-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204020-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204020-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204020-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204020-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204020-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204020-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204020-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204020-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204020-001AB1301d65b070ca…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c5702164-60c8-48a6-804b-dcb1bf276974105ef64f-36a7-4eef-8645-ba8dde9276892025-04-02Exact identifier
spl set id: 105ef64f-36a7-4eef-8645-ba8dde927689

Reported adverse events (FAERS/openFDA)#

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