FDA.reportPublic FDA data

NDC 43386-573-03 - 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
43386-573
Requested NDC
43386-573-03
Package NDCs from labels
43386-573-01, 43386-573-05, 43386-573-03
Manufacturer
Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.
Effective date
2024-03-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
METHYLPHENIDATE - Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.2024-03-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-573-01Methylphenidate Hydrochloride100 in 1 BOTTLETABLET1008
43386-573-03Methylphenidate Hydrochloride30 in 1 BOTTLETABLET308
43386-573-05Methylphenidate Hydrochloride500 in 1 BOTTLETABLET5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-573METHYLPHENIDATE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS,INC.]8Current NDC, Legacy NDC, 3 package rows20240322_ec8a8896-077d-4dee-9e10-97172512c5ed.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-573-01EA - Each43386-573cb977b0b-414b-4693-9c8d-cdb189e7edd212016-02-04

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 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDERising Pharma Holdings, Inc.e5cb0740-813f-4dce-8c29-d7680c66e77c2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESun Pharmaceutical Industries, Inc.1a89b390-0cd5-45cb-9e70-20de44652c562025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCc614cf55-b462-4f7e-b19c-6d22a47e509f2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
unii: 4B3SC438HI
RitalinMETHYLPHENIDATE HYDROCHLORIDESandoz Incd6fb2750-cdab-4749-ba0d-7534840a58922025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
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
rxcui: 1091150
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackc87a2000-b75c-41df-8497-7e00a9b41ad42024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091392
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack371346d1-ac7e-491c-a010-ad29cb3d567a2024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackec3d9304-13bc-4f0b-bf14-1a1ea824bd912024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091392
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
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAccord Healthcare, Inc.4f3c91e6-4576-4326-bdab-7d8fb7c09bb82024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack11f4ec97-ed86-48b5-af3a-446b882294cb2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091150
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack13a17c5a-bba7-4c5a-a4f9-2141bcdffa1a2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack1da9dc9e-7e8e-457a-93d4-9c2aee434e692024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091392
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

Reported adverse events (FAERS/openFDA)#

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