FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
69189-2685
11-digit product format
691892685
Labeler code
69189
Product ID
69189-2685_a84b2038-f235-44be-9e1e-8665973ac05a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmethylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA021802
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-12-01
Marketing end
0000-00-00
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69189-2685-12020-01-31C16284748780-19d75b9d0-5f53-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Dexmethylphenidate Hydrochloride Extended-Release Capsules safely and effectively. See full prescribing information for Dexmethylphenidate Hydrochloride Extended-Release Capsules. Dexmethylphenidate Hydrochloride Extended-Release Capsules CII for oral use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-2685-1Dexmethylphenidate HydrochlorideExtended-Release1 in 1 DOSE PACKCAPSULE, EXTENDED RELEASE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-2685DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20160205_c72a641c-6846-4df9-8ff0-fa8036d6ac27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899485dexmethylphenidate HCl 20 MG 24HR Extended Release Oral CapsulePSNc72a641c-6846-4df9-8ff0-fa8036d6ac271
89948524 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDc72a641c-6846-4df9-8ff0-fa8036d6ac271
899485dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral CapsuleSYc72a641c-6846-4df9-8ff0-fa8036d6ac271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-2685-1691892685011 in 1 DOSE PACKHistorical