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 8 of 10 · 182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VenlafaxineVENLAFAXINEBryant Ranch Prepack1471508e-7fe4-43db-94ea-b4df1bcbafa92024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack1a9e207a-aba5-4ecb-b7b6-7c1e38be5ac92024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.9a30e1b5-272b-4109-ad6c-a3c9a895822f2024-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINECadila Pharmaceuticals Limited516e7566-35c2-4a25-88d8-54d9dbc8f6be2024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsdf7e0982-3eb0-4bdf-8f7f-4f4a48476ed72023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP5c558ab8-b4b3-4973-b016-ed5cfcb4d88b2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313581
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack49e5833b-4693-45b5-9abb-1b369eb4086d2023-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEDr. Reddy's Laboratories Inc.9312f4df-63d9-4167-880f-36a8168704422023-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEZydus Lifesciences Limited750333ce-a512-42e1-b9e3-179714b488df2023-09-28Exact identifier
unii: 7D7RX5A8MO
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited1be1be3a-304b-4e31-8732-3352470291912023-09-28Exact identifier
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.dc989aa7-c4ab-4359-a971-523eb477ef9b2023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionse1114c1d-c193-4c0c-ad1c-c17b3fc617232023-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200834
rxcui: 313585
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEZydus Pharmaceuticals USA Inc.db1d16b3-d1a2-4f41-adff-a87c17689aa02023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEBluePoint Laboratories172b3d3d-bdae-47bf-8fba-edd6da1a86492023-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEZydus Pharmaceuticals USA Inc.72efad5f-0909-46a5-aa13-ac24fe015fe62023-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.37aaa8ac-4e0c-4e04-98b5-19b0d90d857c2023-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINEAlembic Pharmaceuticals Inc.67b323a7-a8c9-410f-bff0-0e515bef41a72023-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINE HYDROCHLORIDEAurobindo Pharma Limitedb23637e5-d37f-41b5-ba76-fc053e903bc22023-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINE HYDROCHLORIDERising Pharma Holdings, Inc.20319949-ccf9-477a-a6e3-53502772deb92023-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Effexor XRVENLAFAXINE HYDROCHLORIDEViatris Specialty LLCc848a5d8-ba94-4c84-80e3-0bf35fb8e32e2023-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
rxcui: 313583
rxcui: 313581
unii: 7D7RX5A8MO

Reported adverse events (FAERS/openFDA)#

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