Home NDC 42843-301 NDC 42843-301 - 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 42843-301
Package NDCs from labels 42843-301-10, 42843-301-11
Manufacturer Osmotica Pharmaceutical Corp.
Effective date 2008-06-03
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42843-301-10 Venlafaxine 100 in 1 BOTTLE, PLASTIC TABLET, EXTENDED RELEASE 100 1 42843-301-11 Venlafaxine 10 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 10 1 42843-301-11 Venlafaxine 10 in 1 CARTON TABLET, EXTENDED RELEASE 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42843-301 VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 3 package rows 20080717_8FBA17DA-573A-425B-B1D7-7DDEEEF3C957.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded venlafaxine hydrochloride ACTIVE INGREDIENT 7D7RX5A8MO VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 venlafaxine ACTIVE MOIETY GRZ5RCB1QG VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 black iron oxide INACTIVE INGREDIENT VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 cellulose acetate INACTIVE INGREDIENT VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 colloidal silicon dioxide INACTIVE INGREDIENT VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 hypromellose INACTIVE INGREDIENT VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 lactose INACTIVE INGREDIENT J2B2A4N98G VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 mannitol INACTIVE INGREDIENT 3OWL53L36A VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 microcrystalline cellulose INACTIVE INGREDIENT OP1R32D61U VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 polyethylene glycol INACTIVE INGREDIENT VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 povidone INACTIVE INGREDIENT FZ989GH94E VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE FOR ORAL USE [OSMOTICA PHARMACEUTICAL CORP.] 1 triacetin INACTIVE INGREDIENT XHX3C3X673 VENLAFAXINE (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 2 of 2 · 23 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VENLAFAXINE HYDROCHLORIDE VENLAFAXINE Camber Pharmaceuticals, Inc. 8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd3 2021-10-29 Boxed warning, Warnings, Adverse reactions Exact identifier rxcui: 808753 rxcui: 808751 rxcui: 808748 rxcui: 808744 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE Nivagen Pharmaceuticals, Inc. 45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e1 2021-01-14 Boxed warning, Warnings, Adverse reactions Exact identifier rxcui: 808753 rxcui: 808748 rxcui: 808744 53631CF3-39CF-14FB-A3BF-BEF967541E63 8FBA17DA-573A-425B-B1D7-7DDEEEF3C957 2008-06-03 Boxed warning, Warnings, Adverse reactions Exact identifier spl id: 53631CF3-39CF-14FB-A3BF-BEF967541E63 spl set id: 8FBA17DA-573A-425B-B1D7-7DDEEEF3C957
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.