FDA.reportPublic FDA data

NDC 72162-1306-01 - 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
72162-1306
Requested NDC
72162-1306-01
Package NDCs from labels
72162-1306-1, 72162-1306-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-02-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methylphenidate Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2024-02-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1306-1Methylphenidate Hydrochloride100 in 1 BOTTLETABLET, CHEWABLE100100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1306METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240206_7293dffd-eb01-43d4-b9c4-04f79bec180c.zip

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 5 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC981a2ad8-33f7-4678-9162-9df9685bd4a62023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.91833146-fa95-471a-8b8d-6d36a2db5c9a2023-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210354
rxcui: 1091322
rxcui: 1091389
rxcui: 1091152
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e02023-09-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210354
ndc (product): 31722-928
rxcui: 1091322
rxcui: 1091389
rxcui: 1091152
spl id: 3547512f-45f7-4c6a-8fb0-2144eff24b11
spl set id: bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e0
unii: 4B3SC438HI
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: Z0H242BBR1
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 4ELV7Z65AP
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC59de488c-c3f8-415d-9e9f-9102c090aac82023-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: Z0H242BBR1
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
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
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: Z0H242BBR1

Reported adverse events (FAERS/openFDA)#

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