FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
49884-428
11-digit product format
498840428
Labeler code
49884
Product ID
49884-428_47a67542-0c06-4542-e063-6394a90a8bfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA078992
Marketing category
ANDA
Marketing start
2013-11-19
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmethylphenidate Hydrochloride
Brand name suffix
Extended-Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899461, 899495

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
49884-428-012024-04-21C16284748780-1d6a99b39-43d3-a426-e053-dadaa90af4c2These 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
49884-428-102024-04-21C16284748780-1d6a99b39-43d3-a426-e053-dadaa90af4c2These 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
49884-428-012022-01-28C16284748780-1d6a99b39-43d3-a426-e053-dadaa90af4c2These 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
49884-428-102022-01-28C16284748780-1d6a99b39-43d3-a426-e053-dadaa90af4c2These 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
49884-428-01Dexmethylphenidate HydrochlorideExtended-Release100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10022
49884-428-10Dexmethylphenidate HydrochlorideExtended-Release1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-428-01EA - Each49884-428e78ba05e-693e-49fb-bbe4-7e4804a89be112013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
DEXMETHYLPHENIDATEACTIVE MOIETYM32RH9MFGPDEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
GELATININACTIVE INGREDIENT2G86QN327LDEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UDEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-428DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 2 package rows20240423_4ed9f3c8-c71f-499e-bb91-c19847bf4444.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSN32b3c189-f0f8-4f3e-87da-ce56f583fc42104
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSNbb4f32eb-05c7-449e-8e5a-f45781a58f70104
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCD32b3c189-f0f8-4f3e-87da-ce56f583fc42104
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCDbb4f32eb-05c7-449e-8e5a-f45781a58f70104
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY32b3c189-f0f8-4f3e-87da-ce56f583fc42104
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYbb4f32eb-05c7-449e-8e5a-f45781a58f70104
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSN4ed9f3c8-c71f-499e-bb91-c19847bf444422
899495dexmethylphenidate HCl 30 MG 24HR Extended Release Oral CapsulePSN4ed9f3c8-c71f-499e-bb91-c19847bf444422
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCD4ed9f3c8-c71f-499e-bb91-c19847bf444422
89949524 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD4ed9f3c8-c71f-499e-bb91-c19847bf444422
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY4ed9f3c8-c71f-499e-bb91-c19847bf444422
899495dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY4ed9f3c8-c71f-499e-bb91-c19847bf444422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-428-0149884042801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-428-01) 2013-11-190000-00-00NoNoCurrent
49884-428-10498840428101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-428-10) 2013-11-190000-00-00NoNoCurrent