FDA.reportPublic FDA data

NDC 0781-8843 - 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
0781-8843
Manufacturer
Physicians Total Care, Inc.
Effective date
2010-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methylphenidate Hydrochloride - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-06-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-8843-01Methylphenidate Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-8843METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UCB PHARMA, INC.]31 package rows20061005_6281ca7c-2aec-4f14-b7e4-82401a701c96.zip

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
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BMETHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

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 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate Hydrochloride Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC9e11e093-4ff3-4bed-8fe9-3ee460b473032025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METADATE CDMETHYLPHENIDATE HYDROCHLORIDEAytu BioPharma, Inc.be59f8b4-7842-42cc-9559-bfa747f0baa52025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack9beb136f-020b-4631-b989-c1d26a9846f72025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
methylphenidate hydrochlorideMETHYLPHENIDATE HYDROCHLORIDEActavis Pharma, Inc.ecbb4a30-21ac-42e1-b4e9-6c35344ffc452025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmerican Health Packagingeb9b7377-d918-43fb-8e82-d14c85ed64a82025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLCed004cf0-eb23-43d2-96dc-20c4ad63824f2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091225
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEKVK-Tech, Inc.be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091225
unii: 4B3SC438HI
JORNAY PM Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDEIronshore Pharmaceuticals Inc.d95dede0-b1ff-4489-8f91-3bbe122852bf2025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate Hydrochloride (LA)METHYLPHENIDATE HYDROCHLORIDEDr. Reddy's Laboratories Incd8c14df4-ac05-d69d-9308-58a51d5683292025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
RELEXXIIMETHYLPHENIDATE HYDROCHLORIDEVertical Pharmaceuticals, LLC22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDETrigen Laboratories, LLCdd8d7b6e-c23d-4e16-bb53-959e9127ebc62025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
MethylphenidateMETHYLPHENIDATESandoz Inc1f8983ce-71b8-4c62-830d-e4692ddededa2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Ritalin LAMETHYLPHENIDATE HYDROCHLORIDENovartis Pharmaceuticals Corporationeffd952d-ac94-47bb-b107-589a4934dcca2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
MethylphenidateMETHYLPHENIDATESandoz Inc44386394-d2a3-4483-abe1-6c5c634cc5012025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate hydrochlorideMETHYLPHENIDATE HYDROCHLORIDESolco Healthcare US,LLC238ff743-4f25-43a3-87ac-6559d12a9d492025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical Inc778190da-1528-4def-94bf-ee23ee5268a52025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack5a22dd9b-9b48-4c96-8b20-0d20131521dc2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack1c7d7e6c-4e96-4d18-8dca-203ef50766ec2025-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDERising Pharma Holdings, Inc.e5cb0740-813f-4dce-8c29-d7680c66e77c2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESun Pharmaceutical Industries, Inc.1a89b390-0cd5-45cb-9e70-20de44652c562025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI

Reported adverse events (FAERS/openFDA)#

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