FDA.reportPublic FDA data

NDC 68084-805-11 - 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
68084-805
Requested NDC
68084-805-11
Package NDCs from labels
68084-805-11, 68084-805-21
Manufacturer
American Health Packaging
Effective date
2025-10-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methylphenidate Hydrochloride - American Health PackagingAmerican Health Packaging2025-10-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-805-11Methylphenidate Hydrochloride1 in 1 BLISTER PACKTABLET111
68084-805-21Methylphenidate Hydrochloride30 in 1 BOX, UNIT-DOSETABLET3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-805METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20241010_eb9b7377-d918-43fb-8e82-d14c85ed64a8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-805-11EA - Each68084-8050e6a9be9-bae1-42a2-9895-ea9ab06f299412014-10-03
68084-805-21EA - Each68084-805e53d3e82-a5a7-484f-8a32-a7eadde4f5b412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2

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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate Hydrochloride Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC9e11e093-4ff3-4bed-8fe9-3ee460b473032025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METADATE CDMETHYLPHENIDATE HYDROCHLORIDEAytu BioPharma, Inc.be59f8b4-7842-42cc-9559-bfa747f0baa52025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack9beb136f-020b-4631-b989-c1d26a9846f72025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091150
unii: 4B3SC438HI
methylphenidate hydrochlorideMETHYLPHENIDATE HYDROCHLORIDEActavis Pharma, Inc.ecbb4a30-21ac-42e1-b4e9-6c35344ffc452025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmerican Health Packagingeb9b7377-d918-43fb-8e82-d14c85ed64a82025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040300
ndc (package): 68084-823-11
ndc (package): 68084-805-11
ndc (package): 68084-805-21
ndc (package): 68084-823-21
ndc (product): 68084-805
ndc (product): 68084-823
ndc11 (package): 68084080511
rxcui: 1091497
rxcui: 1091150
spl id: 41c22d0f-0fbe-e5af-e063-6294a90a47c0
spl set id: eb9b7377-d918-43fb-8e82-d14c85ed64a8
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLCed004cf0-eb23-43d2-96dc-20c4ad63824f2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEKVK-Tech, Inc.be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
JORNAY PM Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDEIronshore Pharmaceuticals Inc.d95dede0-b1ff-4489-8f91-3bbe122852bf2025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate Hydrochloride (LA)METHYLPHENIDATE HYDROCHLORIDEDr. Reddy's Laboratories Incd8c14df4-ac05-d69d-9308-58a51d5683292025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
RELEXXIIMETHYLPHENIDATE HYDROCHLORIDEVertical Pharmaceuticals, LLC22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDETrigen Laboratories, LLCdd8d7b6e-c23d-4e16-bb53-959e9127ebc62025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
MethylphenidateMETHYLPHENIDATESandoz Inc1f8983ce-71b8-4c62-830d-e4692ddededa2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Ritalin LAMETHYLPHENIDATE HYDROCHLORIDENovartis Pharmaceuticals Corporationeffd952d-ac94-47bb-b107-589a4934dcca2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
MethylphenidateMETHYLPHENIDATESandoz Inc44386394-d2a3-4483-abe1-6c5c634cc5012025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4B3SC438HI
Methylphenidate hydrochlorideMETHYLPHENIDATE HYDROCHLORIDESolco Healthcare US,LLC238ff743-4f25-43a3-87ac-6559d12a9d492025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
unii: 4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical Inc778190da-1528-4def-94bf-ee23ee5268a52025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
rxcui: 1091150
rxcui: 1091392
unii: 4B3SC438HI
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack5a22dd9b-9b48-4c96-8b20-0d20131521dc2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
unii: 4B3SC438HI
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack1c7d7e6c-4e96-4d18-8dca-203ef50766ec2025-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1091497
unii: 4B3SC438HI

Reported adverse events (FAERS/openFDA)#

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