FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
49884-539
11-digit product format
498840539
Labeler code
49884
Product ID
49884-539_8b31cc06-5281-497a-a94c-6ce2ec72d1d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA202842
Marketing category
ANDA
Marketing start
2017-01-05
Marketing end
0000-00-00
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49884-539-012022-10-05C16284748780-1e4f33bdf-a7e7-d8a0-e053-dadaa90a6e4eThese 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, for oral use, CII Initial U.S. Approval: 2005
49884-539-012022-07-29C16284748780-1e4f33bdf-a7e7-d8a0-e053-dadaa90a6e4eThese 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, for oral use, CII Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-539-01Dexmethylphenidate Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-539DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]12Legacy NDC, 1 package rows20250116_e304388e-86a6-4335-abae-0ce79c7c99c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899439dexmethylphenidate HCl 10 MG 24HR Extended Release Oral CapsulePSNe304388e-86a6-4335-abae-0ce79c7c99c613
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSNe304388e-86a6-4335-abae-0ce79c7c99c613
899485dexmethylphenidate HCl 20 MG 24HR Extended Release Oral CapsulePSNe304388e-86a6-4335-abae-0ce79c7c99c613
1101926dexmethylphenidate HCl 25 MG 24HR Extended Release Oral CapsulePSNe304388e-86a6-4335-abae-0ce79c7c99c613
899495dexmethylphenidate HCl 30 MG 24HR Extended Release Oral CapsulePSNe304388e-86a6-4335-abae-0ce79c7c99c613
1101932dexmethylphenidate HCl 35 MG 24HR Extended Release Oral CapsulePSNe304388e-86a6-4335-abae-0ce79c7c99c613
1006608dexmethylphenidate HCl 40 MG 24HR Extended Release Oral CapsulePSNe304388e-86a6-4335-abae-0ce79c7c99c613
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSNe304388e-86a6-4335-abae-0ce79c7c99c613
89943924 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCDe304388e-86a6-4335-abae-0ce79c7c99c613
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCDe304388e-86a6-4335-abae-0ce79c7c99c613
89948524 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDe304388e-86a6-4335-abae-0ce79c7c99c613
110192624 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral CapsuleSCDe304388e-86a6-4335-abae-0ce79c7c99c613
89949524 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCDe304388e-86a6-4335-abae-0ce79c7c99c613
110193224 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral CapsuleSCDe304388e-86a6-4335-abae-0ce79c7c99c613
100660824 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCDe304388e-86a6-4335-abae-0ce79c7c99c613
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCDe304388e-86a6-4335-abae-0ce79c7c99c613
899439dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral CapsuleSYe304388e-86a6-4335-abae-0ce79c7c99c613
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYe304388e-86a6-4335-abae-0ce79c7c99c613
899485dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral CapsuleSYe304388e-86a6-4335-abae-0ce79c7c99c613
1101926dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral CapsuleSYe304388e-86a6-4335-abae-0ce79c7c99c613
899495dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSYe304388e-86a6-4335-abae-0ce79c7c99c613
1101932dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral CapsuleSYe304388e-86a6-4335-abae-0ce79c7c99c613
1006608dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral CapsuleSYe304388e-86a6-4335-abae-0ce79c7c99c613
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSYe304388e-86a6-4335-abae-0ce79c7c99c613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-539-0149884053901100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-539-01) 2017-01-050000-00-00NoNoCurrent