FDA.reportPublic FDA data

NDC 80425-0290-01 - 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
80425-0290
Requested NDC
80425-0290-01
Package NDCs from labels
80425-0290-1, 80425-0290-2, 80425-0290-3, 80425-0290-01
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
80425-0290-1Venlafaxine HydrochlorideER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
80425-0290-2Venlafaxine HydrochlorideER60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
80425-0290-3Venlafaxine HydrochlorideER90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0290VENLAFAXINE HYDROCHLORIDE ER (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f7a9741b-2dd3-d8f3-e053-6294a90a4d73.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0290-1EA - Each80425-02908d959310-e6d9-4e6d-8b2b-e6658935aa6a12023-04-07
80425-0290-2EA - Each80425-029084ab351a-50d8-4c18-8f2c-31ae6171348f12023-04-07
80425-0290-3EA - Each80425-0290152622f2-53b0-4e64-a257-dddf4a517ab312023-04-07

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 6 of 10 · 182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HCL ERVENLAFAXINE HCL ERDirect_Rxe20b7d9e-f755-4325-e053-2995a90ac45d2025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 313583
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2c2bb0e6-5a73-ff57-e063-6294a90a88d32025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDEVENLAFAXINEBluePoint Laboratories5efe1336-c796-4560-8110-a64c80eefb0c2025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HCL ERVENLAFAXINE HCLAdvanced Rx Pharmacy of Tennessee, LLCd8e00b3d-29de-1de5-e053-2995a90acb512024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine hydrochloride ERVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8fd4381-52f2-d9c1-e053-6394a90a08e52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine Hydrochloride ERVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf7a9741b-2dd3-d8f3-e053-6294a90a4d732024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214654
ndc (package): 80425-0290-2
ndc (package): 80425-0290-1
ndc (package): 80425-0290-3
ndc (product): 80425-0290
ndc11 (package): 80425029001
rxcui: 313583
spl id: 2a9bad62-b303-697c-e063-6294a90aa395
spl set id: f7a9741b-2dd3-d8f3-e053-6294a90a4d73
unii: 7D7RX5A8MO
Venlafaxine hydrochloride ERVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf89bcae0-e714-599a-e053-6294a90a2c3a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2a85bd43-419c-6ed7-e063-6294a90a84d42024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214654
rxcui: 313585
rxcui: 313583
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINEA-S Medication Solutionsab58f3ef-1fd3-4c68-861f-20d8fdd1b4332024-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEModavar Pharmaceuticals LLC14b38374-7287-47dd-8ef9-e88bd5b23a262024-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals Inc.2787aaa2-5210-f7d5-e063-6294a90a71032024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8906ed5a-f69c-0eac-e053-2995a90ae6002024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack20a7d922-7f7c-4de4-b5fd-55c13aab060c2024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP9f697c00-f5ec-454a-a66c-503aef5fc6092024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313585
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP613658d3-7eb5-4822-961f-f4c6f6b2a2c12024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313581
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LPadeba7dd-bd15-4d8f-b703-24c3a208e7402024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313583
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackbaae24d6-e425-4cfc-9a53-3cd223b6d3442024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313583
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack1e1119f7-0c2e-4587-a24d-0066f73b2e652024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313581
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEBryant Ranch Prepack185d90ab-1ba4-dd59-0565-e35f0fd39a2d2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited51334651-7a7f-4653-bf9d-d5be04fd902d2024-08-14Exact identifier
unii: 7D7RX5A8MO

Reported adverse events (FAERS/openFDA)#

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