FDA.reportPublic FDA data

NDC 80425-0471-01 - Venlafaxine Hydrochloride

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
80425-0471
Requested NDC
80425-0471-01
Package NDCs from labels
80425-0471-1, 80425-0471-3, 80425-0471-2, 80425-0471-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-01-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Venlafaxine Hydrochloride - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-01-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0471-1Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
80425-0471-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
80425-0471-3Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0471VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250122_2c2bb0e6-5a73-ff57-e063-6294a90a88d3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0471-1EA - Each80425-0471a8315624-bb0f-4e0f-9f55-e703d97cde7e12025-03-04
80425-0471-2EA - Each80425-0471fb0f63cc-ca48-49f6-a65e-381c961f81d012025-03-04
80425-0471-3EA - Each80425-0471b58da282-5465-4783-9a43-d6895f58219012025-03-04

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 118 · 2,344 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
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.c41d847b-88ba-49a5-9d73-269ac4caa4ed2026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212277
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
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Venlafaxine HydrochlorideVENLAFAXINEREMEDYREPACK INC.9df3a51c-1b89-4d2a-8f41-3755910e9bfb2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.33b39416-7981-46fb-ba31-e933a6afcf8b2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
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
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIAShenzhen Finona Information Technology Co., Ltd3874ec89-0f1d-87b9-e063-6394a90a300a2026-08-24WarningsExact identifier
unii: 5138Q19F1X
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSHodayfa Abu Alkian524e002c-f509-9395-e063-6394a90acd9e2026-08-20WarningsExact identifier
unii: 5138Q19F1X
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-08-19WarningsExact identifier
unii: 5138Q19F1X

Reported adverse events (FAERS/openFDA)#

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