FDA.reportPublic FDA data

NDC 72162-2086-01 - 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
72162-2086
Requested NDC
72162-2086-01
Package NDCs from labels
72162-2086-1, 72162-2086-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-04-03
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 Prepack2024-04-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2086-1METHYLPHENIDATE HYDROCHLORIDE100 in 1 BOTTLETABLET100101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2086METHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240418_11f4ec97-ed86-48b5-af3a-446b882294cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2086-1EA - Each72162-20864ae3396f-36b8-4685-b198-d9a2d703d7ac12023-10-16

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 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application number: ANDA091159
ndc (product): 0115-1801
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
spl id: 973233cb-8cb1-4c1d-911e-649df1287843
spl set id: c614cf55-b462-4f7e-b19c-6d22a47e509f
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
application number: ANDA091159
ndc (package): 72162-2086-1
ndc (product): 72162-2086
ndc11 (package): 72162208601
rxcui: 1091150
spl id: 11f4ec97-ed86-48b5-af3a-446b882294cb
spl set id: 11f4ec97-ed86-48b5-af3a-446b882294cb
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack13a17c5a-bba7-4c5a-a4f9-2141bcdffa1a2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091159
rxcui: 1091497
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack1da9dc9e-7e8e-457a-93d4-9c2aee434e692024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091159
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
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.ec8a8896-077d-4dee-9e10-97172512c5ed2024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
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

Reported adverse events (FAERS/openFDA)#

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