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 1 of 4 · 78 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
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
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEGolden State Medical Supply, Inc.98be5c84-b348-6b8e-e053-2995a90ae4cc2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
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
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
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.