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 4 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.ec8a8896-077d-4dee-9e10-97172512c5ed2024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207884
ndc (package): 43386-575-05
ndc (package): 43386-574-05
ndc (package): 43386-575-01
ndc (package): 43386-573-05
ndc (package): 43386-574-03
ndc (package): 43386-573-03
ndc (package): 43386-573-01
ndc (package): 43386-575-03
ndc (package): 43386-574-01
ndc (product): 43386-573
ndc (product): 43386-575
ndc (product): 43386-574
ndc11 (package): 43386057303
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
spl id: ac26e6b6-2be0-458d-8acc-d963bcca13a5
spl set id: ec8a8896-077d-4dee-9e10-97172512c5ed
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENivagen Pharmaceuticals, Inc.4cc16009-44ad-4055-ac76-efa282f1ff472024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack7293dffd-eb01-43d4-b9c4-04f79bec180c2024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack213ca0da-dde8-48ee-ac8c-c66558e6f62d2024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackb49863bd-20ba-44d5-8dab-96fcbd276a5c2024-01-10Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.57fd619e-687d-403c-a77a-3dc3a1bab65a2023-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.5bfe50ed-171f-4c40-bc0b-20c68e8e20252023-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEEywa Pharma Inc298fb86d-7d94-49e1-b743-3e78011224222023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
MethylinMETHYLPHENIDATE HYDROCHLORIDESHIONOGI INC.9e3c22d9-71d9-46a7-b315-8021c94c4bec2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC981a2ad8-33f7-4678-9162-9df9685bd4a62023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.91833146-fa95-471a-8b8d-6d36a2db5c9a2023-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e02023-09-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC59de488c-c3f8-415d-9e9f-9102c090aac82023-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAscend Laboratories, LLC5fa3da25-13aa-4ee3-acf5-cd505f4688d02021-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals Inc94dc74d4-b4ef-45bc-b502-54ec692e9bd52021-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals, Inc.b9af3104-172d-4975-9301-b9fe7db9ef122021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.b07150db-fd99-4400-bb83-b3a7544a917a2021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HClMETHYLPHENIDATE HCLPatrin Pharma, Inc.7d66dbf9-3966-4949-b7c9-d2ca8c7f32782020-04-22Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI

Reported adverse events (FAERS/openFDA)#

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