VENLAFAXINE extended-release tablets, for oral use

Manufacturer
Zydus Lifesciences Limited
Effective date
2023-09-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:53:40

Label at a glance#

ProductVenlafaxine
Active ingredientVENLAFAXINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Venlafaxine extended-release tablets, 37.5 mg

NDC 70771-1649-3

30 Tablets

Rx only

37.5 mg label
37.5 mg label

Venlafaxine extended-release tablets, 75 mg

NDC 70771-1650-3

30 Tablets

Rx only

75 mg label
75 mg label

Venlafaxine extended-release tablets, 150 mg

NDC 70771-1651-3

30 Tablets

Rx only

150 mg label
150 mg label

Venlafaxine extended-release tablets, 225 mg

NDC 70771-1652-3

30 Tablets

Rx only

225 mg label
225 mg label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN2
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN2
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSN2
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN2
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD2
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD2
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCD2
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD2
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY2
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY2
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY2
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY2
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY2
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSY2
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY2
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
VENLAFAXINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1649-1Venlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
70771-1649-3Venlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
70771-1649-9Venlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE902
70771-1650-1Venlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
70771-1650-3Venlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
70771-1650-9Venlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE902
70771-1651-1Venlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
70771-1651-3Venlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
70771-1651-9Venlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE902
70771-1652-1Venlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
70771-1652-3Venlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
70771-1652-9Venlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1649VENLAFAXINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 3 package rows20231005_750333ce-a512-42e1-b9e3-179714b488df.zip
70771-1650VENLAFAXINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 3 package rows20231005_750333ce-a512-42e1-b9e3-179714b488df.zip
70771-1651VENLAFAXINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 3 package rows20231005_750333ce-a512-42e1-b9e3-179714b488df.zip
70771-1652VENLAFAXINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 3 package rows20231005_750333ce-a512-42e1-b9e3-179714b488df.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 48 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 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215622-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30
A215622-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30
A215622-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30
A215622-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A215622-001AB
A215622-002AB
A215622-003AB
A215622-004AB

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 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30c2088c7a36db…
2026-10-15 13:18:302026-09A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30c2088c7a36db…
2026-10-15 13:18:302026-09A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30c2088c7a36db…
2026-10-15 13:18:302026-09A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30c2088c7a36db…
2026-09-14 22:38:342026-08A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3084e616aacf4f…
2026-09-14 22:38:342026-08A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3084e616aacf4f…
2026-09-14 22:38:342026-08A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3084e616aacf4f…
2026-09-14 22:38:342026-08A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3084e616aacf4f…
2026-08-18 06:07:402026-07A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-302680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A215622-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A215622-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A215622-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A215622-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A215622-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215622-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A215622-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A215622-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A215622-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215622-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215622-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215622-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215622-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215622-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-004AB12680178bc6a6…

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
VenlafaxineVENLAFAXINEZydus Lifesciences Limited750333ce-a512-42e1-b9e3-179714b488df2023-09-28Exact identifier
ndc (package): 70771-1650-1
ndc (package): 70771-1650-3
ndc (package): 70771-1651-9
ndc (package): 70771-1651-3
ndc (package): 70771-1652-1
ndc (package): 70771-1652-3
ndc (package): 70771-1649-3
ndc (package): 70771-1649-9
ndc (package): 70771-1651-1
ndc (package): 70771-1649-1
ndc (package): 70771-1652-9
ndc (package): 70771-1650-9
ndc (product): 70771-1650
ndc (product): 70771-1652
ndc (product): 70771-1649
ndc (product): 70771-1651
ndc11 (package): 70771165101
ndc11 (package): 70771165001
ndc11 (package): 70771165003
ndc11 (package): 70771165103
ndc11 (package): 70771164901
ndc11 (package): 70771165009
ndc11 (package): 70771165203
ndc11 (package): 70771165209
ndc11 (package): 70771165201
ndc11 (package): 70771164909
ndc11 (package): 70771164903
ndc11 (package): 70771165109
spl id: 0bf02fa2-e5cd-42d6-ab41-1ecd150b7c57
spl set id: 750333ce-a512-42e1-b9e3-179714b488df

Reported adverse events (FAERS/openFDA)#

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