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 7 of 10 · 182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VenlafaxineVENLAFAXINEAmerican Health Packagingd8899628-6e1b-40c6-9bc8-553d91ae2d0c2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECamber Pharmaceuticals, Inc.0ee91447-2c23-4519-81cc-550b5416dd6b2024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEAscend Laboratories, LLC528d5392-4ad5-48c5-963d-6ebfb9187db42024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.1e04fe02-88c9-dafd-e063-6294a90ac4c92024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.1ce9121b-aaa0-a5bb-e063-6394a90a2f3c2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINEProficient Rx LPded77a84-e6d1-4471-ac6e-a05a0955daa52024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINEProficient Rx LP470ad045-6c82-4e44-8e88-0e2b01a41ff22024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1bf78b22-a0e3-5f9f-e063-6394a90a30242024-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313583
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.9d38eac0-9d64-1274-e053-2995a90a189a2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313583
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8f9d3d30-e9a6-6c85-e053-2a95a90a55242024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs9c061460-3b80-41e1-a87a-1a25108ff7402024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313581
unii: 7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEAlembic Pharmaceuticals Limitede3e238db-4388-49bb-aa67-6d73adbb22802024-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6cb943a8-5972-292f-e053-2991aa0ae3ee2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC19b1543e-d599-a869-e063-6294a90a8e282024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackbff505db-2752-41fc-a4dd-4773f629106e2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313583
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack04340ccb-c3b3-41ab-a4bc-101d8b6bc1a92024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEQUALLENT PHARMACEUTICALS HEALTH LLCcb4c04a6-47d1-44ff-8d58-718102fa08eb2024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack304bda24-9151-47b5-9f62-005ea325a11e2024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINEBryant Ranch Prepack0c9511a2-c581-44cd-bf38-a751fcc658e42024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAurobindo Pharma Limited85d3ce8b-8966-45d9-bdaf-f6f0475096e12024-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
ndc (product): 65862-528
rxcui: 313585
rxcui: 313583
rxcui: 313581
spl id: d3f9b554-05be-484f-b9e7-5c8e6b2de9c9
spl set id: 85d3ce8b-8966-45d9-bdaf-f6f0475096e1
unii: 7D7RX5A8MO

Reported adverse events (FAERS/openFDA)#

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