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 1 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLC768bf181-d0d8-49e5-9c87-cacbb069e0b22026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEGranules Pharmaceuticals Inc.45d33807-88b2-4b42-9c86-e5b05d7adec12026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091225
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESun Pharmaceutical Industries, Inc.18024571-4505-6d51-e063-6294a90a19722026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAurolife Pharma, LLC35be77db-fbe3-487e-a220-a08a11aaec282026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEGolden State Medical Supply, Inc.98be5c84-b348-6b8e-e053-2995a90ae4cc2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091225
unii: 4B3SC438HI
methylphenidate hydrochloride CDMETHYLPHENIDATE HYDROCHLORIDELannett Company, LLCe45c75dc-d381-475b-b649-a871c8a36e602026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METADATE CDMETHYLPHENIDATE HYDROCHLORIDELannett Company, LLC29f06562-6b6a-4ca6-b62e-d08a45fb3dd42026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELannett Company, Inc.44737c1d-fe75-409e-8a58-591696d3d7aa2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC10aa0dc0-bd0e-4927-a19a-8722d78ad67d2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
MethylphenidateMETHYLPHENIDATE HYDROCHLORIDEKVK-Tech, Inc.2cf1b26b-199d-4c7f-ab64-4805a9def2cc2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELannett Company, Inc.3d1f5aff-5d39-496c-b5ed-7f3c70ec641c2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEActavis Pharma, Inc.85ef422d-af27-4126-9841-6892af1871d62026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDETrigen Laboratories, LLCc45dc1de-adfa-4b3c-a7dc-cffbc8eac74f2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEGolden State Medical Supply, Inc.22e5ddfa-7264-fbb1-e063-6394a90a64832026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
CONCERTAMETHYLPHENIDATE HYDROCHLORIDEJanssen Pharmaceuticals, Inc.1a88218c-5b18-4220-8f56-526de1a276cd2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Quillivant XRMETHYLPHENIDATE HYDROCHLORIDENextWave Pharmaceuticals, Incc2dc2109-44a6-4797-b04e-18761dd9d45a2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackcd2c1226-fa19-4734-b62d-89fea73dcb0d2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack5a29687b-5294-4b27-a556-514b092a877d2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEKVK-TECH, INC.1bf37f9f-29cf-4b09-9c81-eb369e35a0422026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmerican Health Packagingf6581305-cd1e-4171-8c1b-e184c7bde0332025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI

Reported adverse events (FAERS/openFDA)#

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