FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
10702-108
11-digit product format
107020108
Labeler code
10702
Product ID
10702-108_445dff50-b3a4-8602-e063-6294a90aef3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
KVK-TECH, INC
Application
ANDA206931
Marketing category
ANDA
Marketing start
2015-12-04
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmethylphenidate Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899518, 899548, 899557

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ff349b0-f325-4585-9c0d-7dc58eb1bc1bProduct name120210818
7d5b6b15-5a1e-e1e5-992d-90d0701572adProduct name920210511
ccfbb2ac-2915-4b21-1d79-8a93f773e70fProduct name920200714

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-108-012024-02-20C16284748780-11030e365-4645-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001
10702-108-012024-01-30C16284748780-11030e365-4645-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-108-01Dexmethylphenidate Hydrochloride100 in 1 BOTTLETABLET10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-108-01EA - Each10702-10846cfc9c3-a3f4-494f-bd93-5afcb92a6e6d12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-108DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [KVK-TECH, INC]13Current NDC, Legacy NDC, 1 package rows20241121_0c717ae4-ec27-47db-ac1b-e504dbb379be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899548dexmethylphenidate HCl 10 MG Oral TabletPSN0c717ae4-ec27-47db-ac1b-e504dbb379be14
899557dexmethylphenidate HCl 2.5 MG Oral TabletPSN0c717ae4-ec27-47db-ac1b-e504dbb379be14
899518dexmethylphenidate HCl 5 MG Oral TabletPSN0c717ae4-ec27-47db-ac1b-e504dbb379be14
899548dexmethylphenidate hydrochloride 10 MG Oral TabletSCD0c717ae4-ec27-47db-ac1b-e504dbb379be14
899557dexmethylphenidate hydrochloride 2.5 MG Oral TabletSCD0c717ae4-ec27-47db-ac1b-e504dbb379be14
899518dexmethylphenidate hydrochloride 5 MG Oral TabletSCD0c717ae4-ec27-47db-ac1b-e504dbb379be14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-108-0110702010801100 TABLET in 1 BOTTLE (10702-108-01) 100 tablet2015-12-040000-00-00NoNoCurrent