FDA.reportPublic FDA data

NDC 80425-0297-02 - 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
80425-0297
Requested NDC
80425-0297-02
Package NDCs from labels
80425-0297-1, 80425-0297-2, 80425-0297-3, 80425-0297-02
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
80425-0297-1Venlafaxine hydrochlorideER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
80425-0297-2Venlafaxine hydrochlorideER60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
80425-0297-3Venlafaxine hydrochlorideER90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0297VENLAFAXINE HYDROCHLORIDE ER (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8fd4381-52f2-d9c1-e053-6394a90a08e5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0297-1EA - Each80425-0297ae76aa7a-5783-4de5-9a3b-07ec0cfadff812023-06-06
80425-0297-2EA - Each80425-0297db1e0438-c808-4f97-a609-e97fac7e5cd112023-06-06
80425-0297-3EA - Each80425-02975e5d014e-23e9-40ef-b341-2f3edfbe67bc12023-06-06

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 1 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
venlafaxine hydrochloride, extended releaseVENLAFAXINE HYDROCHLORIDE, EXTENDED RELEASEEdenbridge Pharmaceuticals LLC.38431a76-6185-4c17-994f-8278b6cd75102026-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.c41d847b-88ba-49a5-9d73-269ac4caa4ed2026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.963e5599-f9af-45c2-8cf4-13cf52eed6a02026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313581
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINEREMEDYREPACK INC.e14bfb9f-3bd2-4419-9294-9c286e79730a2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINEREMEDYREPACK INC.9df3a51c-1b89-4d2a-8f41-3755910e9bfb2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.33b39416-7981-46fb-ba31-e933a6afcf8b2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEAdvagen Pharma Ltd.48a75840-64e4-4d44-9a62-0093730031052026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEREMEDYREPACK INC.1ce5786e-22e6-4afa-8052-6eababc6aa4e2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs3eef522f-9e95-4668-bb12-09fd47ed0daf2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSb1d21366-f686-4e20-a10f-0c25f517db382026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.f56a0f70-bbb1-4e69-b969-965a72f0e2f02026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.4e3053b9-cdec-4f4d-85ae-2e55cf1cc1852026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313583
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.50d3b487-9f65-4e2f-b6eb-9533964f89722026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.ac9b972d-8b8a-4727-90c2-b208f91272fd2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEYaopharma Co., Ltd.38fd2c97-cd30-2f7d-e054-00144ff8d46c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.4a82cef5-693e-46e9-90c4-bff753cdce372026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsf50029b8-7d05-445a-9d9f-71a1aee6088b2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions5a990dbd-f280-4caf-b950-4703ee98b2302026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313583
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsd94e5404-f728-4e4b-af99-8a8e4dfae2272026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsc37a73fa-ceee-4555-a61b-e1e66ad6e97d2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313581
unii: 7D7RX5A8MO

Reported adverse events (FAERS/openFDA)#

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