FDA.reportPublic FDA data

NDC 80425-0296-01 - Venlafaxine hydrochloride ER

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0296
Requested NDC
80425-0296-01
Package NDCs from labels
80425-0296-1, 80425-0296-2, 80425-0296-3, 80425-0296-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Venlafaxine hydrochloride ER - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0296-1Venlafaxine hydrochlorideER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
80425-0296-2Venlafaxine hydrochlorideER60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
80425-0296-3Venlafaxine hydrochlorideER90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0296VENLAFAXINE HYDROCHLORIDE ER (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f89bcae0-e714-599a-e053-6294a90a2c3a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0296-1EA - Each80425-029619a8e1c7-fca1-48d6-905f-9e3760d8d66012023-06-06
80425-0296-2EA - Each80425-029608f25694-74d0-4109-869d-0deeaaad811e12023-06-06
80425-0296-3EA - Each80425-0296c596b70e-071d-4424-9450-f764a0f86cf812023-06-06

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 2 of 10 · 182 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
unii: 7D7RX5A8MO
VENLAFAXINEVENLAFAXINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.80ac757d-c629-4579-8afd-cae0ee9cd6142026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.7fcd7995-81fb-4368-bd4c-3726b2ae363e2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313583
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINE HYDROCHLORIDECoupler LLC53e5c5a2-b8e7-3d75-e063-6294a90a508b2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINECoupler LLC53c29dd9-a4d2-7537-e063-6294a90a290f2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECoupler LLC5358f20f-b864-0aae-e063-6394a90a7eab2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECoupler LLC5359012e-a868-3aa3-e063-6294a90a74e22026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313583
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINESt Mary's Medical Park Pharmacy70d47b50-5722-3868-e053-2991aa0af85e2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINECoupler LLC52ce8a81-d7fc-cc97-e063-6394a90a52362026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDENorthStar RxLLCb865c175-e75d-4cb4-ac29-dec72226302c2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEMacleods Pharmaceuticals Limited3e51f786-3691-4ec4-836b-7f2c9a385aa72026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAsclemed USA, Inc.c69d16fd-b82d-4708-aece-ab4f60b29cc62026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEPD-Rx Pharmaceuticals, Inc.18495527-add4-42a5-bbf7-9f8dc2df06af2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack7aa3edba-4248-49bb-86f7-06fdbf2a6fb72026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313583
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepacke2fa1bb0-ab86-4499-84cb-ff5e02a169912026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.1775b8bf-cd4f-4a8a-abd1-78d90de54fdd2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEGolden State Medical Supply, Inc.c2a3283f-ba30-f506-e053-2995a90a93782026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEGranules Pharmaceuticals Inc.67059969-e291-4609-b130-0faacf2a19f02026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2a7d760c-fd9f-8026-e063-6294a90aaa432026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313583
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions7852be9e-0c1d-47a8-9513-c3a04b3657632026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO

Reported adverse events (FAERS/openFDA)#

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