FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
49884-048
11-digit product format
498840048
Labeler code
49884
Product ID
49884-048_09fcee97-8b48-4a1d-a380-0e01c92e0e9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA202842
Marketing category
ANDA
Marketing start
2017-01-05
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899439, 899461, 899485, 899495, 899511, 1006608, 1101926, 1101932

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
49884-048-012022-10-05C16284748780-1e4f33bdf-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
49884-048-012022-07-29C16284748780-1e4f33bdf-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
49884-048-01Dexmethylphenidate Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-048-01EA - Each49884-048ea7323a4-6998-4f64-985d-0051ad1af66612017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-048DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]12Current NDC, Legacy NDC, 1 package rows20250116_e304388e-86a6-4335-abae-0ce79c7c99c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSNd3318fec-a1bc-4e3c-86a9-3f00ec296869104
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCDd3318fec-a1bc-4e3c-86a9-3f00ec296869104
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSYd3318fec-a1bc-4e3c-86a9-3f00ec296869104
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSNb64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe102
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCDb64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe102
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSYb64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe102
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
49884-048-0149884004801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-048-01) 2017-01-050000-00-00NoNoCurrent