FDA.reportPublic FDA data

NDC 42843-303-11 - Venlafaxine

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
42843-303
Requested NDC
42843-303-11
Package NDCs from labels
42843-303-10, 42843-303-11
Manufacturer
Osmotica Pharmaceutical Corp.
Effective date
2008-06-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Venlafaxine - Osmotica Pharmaceutical Corp.Osmotica Pharmaceutical Corp.2008-06-03HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42843-303-10Venlafaxine100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1001
42843-303-11Venlafaxine10 in 1 CARTONTABLET, EXTENDED RELEASE101
42843-303-11Venlafaxine10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42843-303VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]13 package rows20080717_8FBA17DA-573A-425B-B1D7-7DDEEEF3C957.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
venlafaxine hydrochlorideACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
venlafaxineACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
black iron oxideINACTIVE INGREDIENTVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
cellulose acetateINACTIVE INGREDIENTVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
colloidal silicon dioxideINACTIVE INGREDIENTVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
hypromelloseINACTIVE INGREDIENTVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
mannitolINACTIVE INGREDIENT3OWL53L36AVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
polyethylene glycolINACTIVE INGREDIENTVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
povidoneINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1
triacetinINACTIVE INGREDIENTXHX3C3X673VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.]1

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 2 · 23 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
rxcui: 808748
rxcui: 808744
Venlafaxine HydrochlorideVENLAFAXINEREMEDYREPACK INC.9df3a51c-1b89-4d2a-8f41-3755910e9bfb2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
VenlafaxineVENLAFAXINEREMEDYREPACK INC.1ce5786e-22e6-4afa-8052-6eababc6aa4e2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
VenlafaxineVENLAFAXINEREMEDYREPACK INC.570beece-6f30-4850-a3bc-636e7cf8d4232026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEChartwell RX, LLC85ec2d3f-49e4-4ac5-bd4a-c227589dbf582025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808748
VenlafaxineVENLAFAXINEAjanta Pharma USA Inc.22d4817c-1f19-4490-8a38-d8904f0374f72025-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
rxcui: 808751
rxcui: 808748
rxcui: 808744
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC349308ef-2caf-4fec-b428-56ae06c6771d2025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808748
rxcui: 808744
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDETrigen Laboratories, LLCfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c972025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
rxcui: 808751
rxcui: 808748
rxcui: 808744
Venlafaxine HydrochlorideVENLAFAXINERising Pharma Holdings, Inc.074f4478-e81b-45a2-ae85-ffd27bed940f2025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
rxcui: 808751
rxcui: 808748
rxcui: 808744
Venlafaxine HydrochlorideVENLAFAXINEPreferred Pharmaceuticals Inc.edefc932-d25d-4ead-b348-b3b6d92320912025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2cf6e6ad-7d00-0db1-e063-6394a90ab1ec2025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808751
VENLAFAXINE HYDROCHLORIDEVENLAFAXINEBluePoint Laboratories5efe1336-c796-4560-8110-a64c80eefb0c2025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
rxcui: 808751
rxcui: 808748
rxcui: 808744
VenlafaxineVENLAFAXINEModavar Pharmaceuticals LLC14b38374-7287-47dd-8ef9-e88bd5b23a262024-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
rxcui: 808748
rxcui: 808744
VenlafaxineVENLAFAXINEAscend Laboratories, LLC528d5392-4ad5-48c5-963d-6ebfb9187db42024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
rxcui: 808751
rxcui: 808748
rxcui: 808744
VenlafaxineVENLAFAXINECadila Pharmaceuticals Limited516e7566-35c2-4a25-88d8-54d9dbc8f6be2024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
rxcui: 808748
rxcui: 808744
VenlafaxineVENLAFAXINEDr. Reddy's Laboratories Inc.9312f4df-63d9-4167-880f-36a8168704422023-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808748
rxcui: 808744
VenlafaxineVENLAFAXINEZydus Lifesciences Limited750333ce-a512-42e1-b9e3-179714b488df2023-09-28Exact identifier
rxcui: 808753
rxcui: 808751
rxcui: 808748
rxcui: 808744
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.dc989aa7-c4ab-4359-a971-523eb477ef9b2023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
rxcui: 808751
rxcui: 808748
rxcui: 808744
VenlafaxineVENLAFAXINEZydus Pharmaceuticals USA Inc.db1d16b3-d1a2-4f41-adff-a87c17689aa02023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
rxcui: 808751
rxcui: 808748
rxcui: 808744
VENLAFAXINE HYDROCHLORIDEVENLAFAXINEXLCare Pharmaceuticals, Inc.68f40801-d35e-464e-ac94-21016b617ea22021-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 808753
rxcui: 808751
rxcui: 808748
rxcui: 808744

Reported adverse events (FAERS/openFDA)#

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