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 3 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCc614cf55-b462-4f7e-b19c-6d22a47e509f2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
RitalinMETHYLPHENIDATE HYDROCHLORIDESandoz Incd6fb2750-cdab-4749-ba0d-7534840a58922025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDECranbury Pharmaceuticals, LLCe817377f-bc72-415a-acd2-7136746b24792025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackb77128b3-fce4-4bee-bdad-5fe4af9d612d2024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackc87a2000-b75c-41df-8497-7e00a9b41ad42024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack371346d1-ac7e-491c-a010-ad29cb3d567a2024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackec3d9304-13bc-4f0b-bf14-1a1ea824bd912024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate Hydrochloride Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDESpecGx LLCb1b0f2ff-d9df-42ab-b471-226ecf97e0752024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAscend Laboratories, LLC8e97c9f3-956c-416a-a7c2-68bb92053ce52024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAccord Healthcare, Inc.4f3c91e6-4576-4326-bdab-7d8fb7c09bb82024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack11f4ec97-ed86-48b5-af3a-446b882294cb2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack13a17c5a-bba7-4c5a-a4f9-2141bcdffa1a2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack1da9dc9e-7e8e-457a-93d4-9c2aee434e692024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackb9c31526-d486-433c-9b3c-7a12765afe942024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack83e70f8f-18dd-45fc-8bc5-4b8f7f23439e2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackad3a3865-952e-46cf-8387-1228e23753122024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackea5a6d4e-60ba-46f3-b314-3c7a970b377d2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.ec8a8896-077d-4dee-9e10-97172512c5ed2024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENivagen Pharmaceuticals, Inc.4cc16009-44ad-4055-ac76-efa282f1ff472024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack7293dffd-eb01-43d4-b9c4-04f79bec180c2024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI

Reported adverse events (FAERS/openFDA)#

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