VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES

Manufacturer
Zydus Lifesciences Limited
Effective date
2023-05-19
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:49:27

Label at a glance#

ProductVenlafaxine Hydrochloride
Active ingredientVENLAFAXINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1836-9

Venlafaxine Hydrochloride Extended-release Capsules USP, 37.5 mg

90 Capsules

Rx only

37.5 mg label
37.5 mg label

NDC 70771-1837-9

Venlafaxine Hydrochloride Extended-release Capsules USP, 75 mg

90 Capsules

Rx only

75 mg label
75 mg label

NDC 70771-1838-9

Venlafaxine Hydrochloride Extended-release Capsules USP, 150 mg

90 Capsules

Rx only

150 mg label
150 mg label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN1
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN1
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN1
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD1
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD1
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD1
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY1
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY1
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY1

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1836-0Venlafaxine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10001
70771-1836-2Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE101
70771-1836-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
70771-1836-4Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE101
70771-1836-5Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
70771-1836-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901
70771-1837-0Venlafaxine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10001
70771-1837-2Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE101
70771-1837-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
70771-1837-4Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE101
70771-1837-5Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
70771-1837-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901
70771-1838-0Venlafaxine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10001
70771-1838-2Venlafaxine Hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE101
70771-1838-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
70771-1838-4Venlafaxine Hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE101
70771-1838-5Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
70771-1838-9Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1836VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 6 package rows20230520_1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b.zip
70771-1837VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 6 package rows20230520_1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b.zip
70771-1838VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 6 package rows20230520_1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 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
A090174-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14
A090174-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14
A090174-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090174-001AB
A090174-002AB
A090174-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1484e616aacf4f…
2026-09-14 22:38:342026-08A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1484e616aacf4f…
2026-09-14 22:38:342026-08A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1484e616aacf4f…
2026-08-18 06:07:402026-07A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090174-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090174-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090174-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090174-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090174-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090174-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090174-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090174-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090174-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090174-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090174-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090174-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090174-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090174-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090174-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090174-001AB1301d65b070ca…

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
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b2023-05-19Exact identifier
ndc (package): 70771-1838-3
ndc (package): 70771-1836-9
ndc (package): 70771-1838-2
ndc (package): 70771-1836-4
ndc (package): 70771-1836-2
ndc (package): 70771-1836-0
ndc (package): 70771-1838-0
ndc (package): 70771-1837-5
ndc (package): 70771-1837-4
ndc (package): 70771-1836-3
ndc (package): 70771-1837-3
ndc (package): 70771-1837-2
ndc (package): 70771-1836-5
ndc (package): 70771-1838-4
ndc (package): 70771-1837-0
ndc (package): 70771-1838-9
ndc (package): 70771-1838-5
ndc (package): 70771-1837-9
ndc (product): 70771-1837
ndc (product): 70771-1838
ndc (product): 70771-1836
ndc11 (package): 70771183602
ndc11 (package): 70771183603
ndc11 (package): 70771183705
ndc11 (package): 70771183803
ndc11 (package): 70771183703
ndc11 (package): 70771183809
ndc11 (package): 70771183704
ndc11 (package): 70771183605
ndc11 (package): 70771183805
ndc11 (package): 70771183800
ndc11 (package): 70771183804
ndc11 (package): 70771183609
ndc11 (package): 70771183700
ndc11 (package): 70771183600
ndc11 (package): 70771183709
ndc11 (package): 70771183604
ndc11 (package): 70771183802
ndc11 (package): 70771183702
spl id: 665f7293-1792-4b57-b8af-3e1fc33e8200
spl set id: 1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b

Reported adverse events (FAERS/openFDA)#

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