FDA.reportPublic FDA data

NDC 0781-8840-01 - Methylphenidate 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
0781-8840
Requested NDC
0781-8840-01
Package NDCs from labels
0781-8840-01
Manufacturer
National Council for Prescription Drug Programs
Effective date
2013-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit
Methylphenidate Hydrochloride - UCB Pharma, Inc.UCB Pharma, Inc.2006-09-19Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-8840-01Methylphenidate Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-8840METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]31 package rows20061005_6281ca7c-2aec-4f14-b7e4-82401a701c96.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-8840-01EA - Each0781-884081df4d55-c154-4438-b89c-9e6491d3873212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
methylphenidate hydrochlorideACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
methylphenidateACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
anhydrous lactoseINACTIVE INGREDIENTMETHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNMETHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
D & C Yellow No. 10INACTIVE INGREDIENTMETHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
ethylcelluloseINACTIVE INGREDIENTMETHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
FD & C Green No. 3INACTIVE INGREDIENTMETHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
FD & C Yellow No. 6INACTIVE INGREDIENTMETHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
lactoseINACTIVE INGREDIENTMETHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
microcrystalline celluloseINACTIVE INGREDIENTMETHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3
sodium starch glycolateINACTIVE INGREDIENTMETHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]3

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 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAccord Healthcare, Inc.4f3c91e6-4576-4326-bdab-7d8fb7c09bb82024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack11f4ec97-ed86-48b5-af3a-446b882294cb2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091150
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack13a17c5a-bba7-4c5a-a4f9-2141bcdffa1a2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack1da9dc9e-7e8e-457a-93d4-9c2aee434e692024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091392
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.ec8a8896-077d-4dee-9e10-97172512c5ed2024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENivagen Pharmaceuticals, Inc.4cc16009-44ad-4055-ac76-efa282f1ff472024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC981a2ad8-33f7-4678-9162-9df9685bd4a62023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals Inc94dc74d4-b4ef-45bc-b502-54ec692e9bd52021-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
C370781C-7880-D65F-0DE9-2B7EA1158E4E6281ca7c-2aec-4f14-b7e4-82401a701c962006-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: C370781C-7880-D65F-0DE9-2B7EA1158E4E
spl set id: 6281ca7c-2aec-4f14-b7e4-82401a701c96

Reported adverse events (FAERS/openFDA)#

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