FDA.reportPublic FDA data

NDC 63629-2307-01 - 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
63629-2307
Requested NDC
63629-2307-01
Package NDCs from labels
63629-2307-1, 63629-2307-01
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
63629-2307-1Dexmethylphenidate Hydrochloride100 in 1 BOTTLE, PLASTICTABLET100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2307DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240112_f88da72d-c22f-413b-9dce-60871299b06a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2307-1EA - Each63629-230711128ea7-13e3-43c7-8677-a3aecb68012b12021-03-02

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 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.dd659d39-41f5-4612-8f17-bad602b4784d2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
AZSTARYSSERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATECommave Sub, LLC00b5e716-5564-4bbd-acaf-df2bc45a56632026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackbb4f32eb-05c7-449e-8e5a-f45781a58f702026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack72d7a084-79cf-44c5-a158-fae1fc2faba42026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack90308fd0-d174-4979-aa22-16290d6cc5bb2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899518
unii: 1678OK0E08
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack76aa2130-2b7b-40f7-a35a-d51b21da46362026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899548
unii: 1678OK0E08
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDEPar Health USA, LLC4ed9f3c8-c71f-499e-bb91-c19847bf44442026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDENivagen Pharmaceuticals, Inc.638f614c-bf91-4bf6-876f-bf25fa273bc42026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899548
rxcui: 899518
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEKVK-TECH, INC0c717ae4-ec27-47db-ac1b-e504dbb379be2025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 899557
rxcui: 899548
rxcui: 899518
unii: 1678OK0E08
DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDEGranules Pharmaceuticals Inc.abe6862b-3cf3-4aad-98ea-05a5fb54ebec2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC93e56455-0f15-4ed9-a63a-7fbd0697d5202025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate hydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCbe7019d7-eb3e-48eb-b6ba-0ffefae6dcd02025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate Hydrochloride Extended-ReleaseDEXMETHYLPHENIDATE HYDROCHLORIDELannett Company, Inc.edad7c67-a872-41ad-a8bd-169278693cc22025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Focalin XRDEXMETHYLPHENIDATE HYDROCHLORIDESandoz Inc9cf76f62-48aa-4065-94fd-6fc910391ab52025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Focalin XRDEXMETHYLPHENIDATE HYDROCHLORIDENovartis Pharmaceuticals Corporation1a1da905-42a0-4748-9c39-67eca45deccc2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackd9c450fa-c8c5-4ff0-a263-4a9eee6f54372024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackb64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackb82e8d08-cc4a-40a6-85a5-07717f3cb38b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08
Dexmethylphenidate HydrochlorideDEXMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackb7410d65-9c7f-4ffd-b957-969e2725f38f2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1678OK0E08

Reported adverse events (FAERS/openFDA)#

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