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 4 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: Z0H242BBR1
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
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
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
application number: ANDA210354
ndc (package): 72162-1306-1
ndc (product): 72162-1306
ndc11 (package): 72162130601
rxcui: 1091152
spl id: 087f3f1a-87dc-4c7a-89db-309439f32fbc
spl set id: 7293dffd-eb01-43d4-b9c4-04f79bec180c
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
rxcui: 1091322
rxcui: 1091389
rxcui: 1091152
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

Reported adverse events (FAERS/openFDA)#

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