Venlafaxine

Product NDC
68071-3432
Requested package NDC
68071-3432-0
11-digit product format
680713432
Labeler code
68071
Product ID
68071-3432_2d5887b5-8622-42a8-e063-6394a90a1b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077653
Marketing category
ANDA
Marketing start
2008-06-13
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-343268071-3432-0UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-343268071-3432-0UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-343268071-3432-0UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077653-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13
A077653-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13
A077653-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13
A077653-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13
A077653-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A077653-001AB
A077653-002AB
A077653-003AB
A077653-004AB
A077653-005AB

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077653-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077653-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-005AB15bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7D7RX5A8MOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313586Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe7de51e-8a81-fe68-e053-6294a90a7339Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3432-02025-02-04C16284748780-12cef2736-a164-d83d-e063-dadaa90ab31fVenlafaxine Tablets, USP
68071-3432-02025-01-30C16284748780-12cef2736-a164-d83d-e063-dadaa90ab31fVenlafaxine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3432-0Venlafaxine100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3432VENLAFAXINE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250206_fe7de51e-8a81-fe68-e053-6294a90a7339.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VenlafaxineVENLAFAXINESt. Mary's Medical Park Pharmacyfab65158-b2f7-1db7-e053-6294a90af2312026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBryant Ranch Prepackd4638a83-2720-430c-b529-c852aa2f73662025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.fa1db21b-98b8-3bde-e053-6394a90aa6382025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEA-S Medication Solutions7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.017a84aa-0e1f-f560-e063-6294a90a90692025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.fe7de51e-8a81-fe68-e053-6294a90a73392025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
ndc (package): 68071-3432-0
ndc (product): 68071-3432
ndc11 (package): 68071343200
VenlafaxineVENLAFAXINEBryant Ranch Prepack185d90ab-1ba4-dd59-0565-e35f0fd39a2d2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited51334651-7a7f-4653-bf9d-d5be04fd902d2024-08-14Exact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEAmerican Health Packagingd8899628-6e1b-40c6-9bc8-553d91ae2d0c2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBryant Ranch Prepack1471508e-7fe4-43db-94ea-b4df1bcbafa92024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBluePoint Laboratories172b3d3d-bdae-47bf-8fba-edd6da1a86492023-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEZydus Pharmaceuticals USA Inc.72efad5f-0909-46a5-aa13-ac24fe015fe62023-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEA-S Medication Solutionsd3475ce0-1368-4961-a9b9-44c5c33cdc582023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEProficient Rx LPb5fc0187-590c-4bb9-a910-821eb0dc1fc82021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313586venlafaxine HCl 75 MG Oral TabletPSNfe7de51e-8a81-fe68-e053-6294a90a73392
313586venlafaxine 75 MG Oral TabletSCDfe7de51e-8a81-fe68-e053-6294a90a73392
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYfe7de51e-8a81-fe68-e053-6294a90a73392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3432-068071343200100 TABLET in 1 BOTTLE (68071-3432-0) 100 tablet2023-06-19NoNoCurrent