FDA.reportPublic FDA data

NDC 63629-2305-01 - Dexmethylphenidate 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
63629-2305
Requested NDC
63629-2305-01
Package NDCs from labels
63629-2305-1, 63629-2305-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-01-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexmethylphenidate Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2024-01-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2305-1Dexmethylphenidate Hydrochloride100 in 1 BOTTLE, PLASTICTABLET100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2305DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240112_194bb3a5-5f6c-49e3-85ab-ac557b3f8bbd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2305-1EA - Each63629-23052f67296d-65ae-4cd0-8c4b-131cd23f6d3c12021-03-02

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 2 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack6593b3ae-efcc-49ff-ba51-3fb5558605e52024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack06bcef7a-b321-4dd8-9bf6-5d8f8940f04a2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepacka03d8819-a315-4337-ac50-530af98082b02024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack424da264-7448-4364-939f-d3ebbee1a6d72024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackd3318fec-a1bc-4e3c-86a9-3f00ec2968692024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackc423a632-e8e0-44a7-a8a8-f66cec81aa642024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDECranbury Pharmaceuticals, LLC1f2aa66a-51dc-459c-a765-5364bccd310f2024-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207901
ndc (product): 27808-091
rxcui: 899557
rxcui: 899548
rxcui: 899518
spl id: 9e21f04a-b4b6-45b8-8da3-5955e6aa18a5
spl set id: 1f2aa66a-51dc-459c-a765-5364bccd310f
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEAscend Laboratories, LLC830df993-db01-40df-beef-90af6b86f5612024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
rxcui: 899548
rxcui: 899518
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackf930af78-760b-42c7-af30-ffcc64c4d35d2024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207901
rxcui: 899518
unii: 1678OK0E08
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepacka0133bf5-3cb3-4405-a007-43fbcf9573332024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack32b3c189-f0f8-4f3e-87da-ce56f583fc422024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
FocalinDEXMETHYLPHENIDATE HYDROCHLORIDESandoz Inc2016f5c2-95d2-4655-af65-c588c2bf5e6d2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
rxcui: 899548
rxcui: 899518
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack17950616-ab96-4d7e-be48-f36cae547de02024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207901
rxcui: 899518
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackf65759db-5294-4e82-bb3c-3ea368edaca72024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207901
rxcui: 899548
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackea04c0e3-0be3-4607-bd59-29f611e6681b2024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207901
rxcui: 899557
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEPar Health USA, LLCe304388e-86a6-4335-abae-0ce79c7c99c62024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.a61932ef-c2b6-4363-a21d-1f0358f317b62024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
rxcui: 899548
rxcui: 899518
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack194bb3a5-5f6c-49e3-85ab-ac557b3f8bbd2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207901
ndc (package): 63629-2305-1
ndc (product): 63629-2305
ndc11 (package): 63629230501
rxcui: 899557
spl id: a94ee633-3b2f-4f07-b250-f061c7d890e4
spl set id: 194bb3a5-5f6c-49e3-85ab-ac557b3f8bbd
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackf88da72d-c22f-413b-9dce-60871299b06a2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207901
rxcui: 899548
unii: 1678OK0E08
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDESun Pharmaceutical Industries, Inc.987b4983-1edc-40f1-adc9-7247470809692024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
rxcui: 899548
rxcui: 899518
unii: 1678OK0E08

Reported adverse events (FAERS/openFDA)#

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