FDA.reportPublic FDA data

NDC 72162-1285-01 - Dexmethylphenidate Hydrochloride

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
72162-1285
Requested NDC
72162-1285-01
Package NDCs from labels
72162-1285-1, 72162-1285-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-02-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexmethylphenidate Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2024-02-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1285-1Dexmethylphenidate Hydrochloride100 in 1 BOTTLE, PLASTICTABLET100100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1285DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240202_17950616-ab96-4d7e-be48-f36cae547de0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1285-1EA - Each72162-12858927108a-2596-4a08-9bcd-05776df6e15f12024-03-12

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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals, Inc.77659abe-74be-4092-90fe-cc475726d4ec2021-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08

Reported adverse events (FAERS/openFDA)#

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