FDA.reportPublic FDA data

Dexmethylphenidate hydrochloride

Product NDC
0115-9920
11-digit product format
001159920
Labeler code
0115
Product ID
0115-9920_4fcd36f9-1e85-437f-9f27-0e2942480c7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA079108
Marketing category
ANDA
Marketing start
2014-11-11
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899439, 899461, 899485, 899495, 899511

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
0115-9920-012021-08-27C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012021-08-27C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012021-08-27C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012020-09-27C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012020-09-27C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012020-09-27C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012020-09-25C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012020-09-25C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012020-09-25C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012020-07-22C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012020-07-22C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-012020-07-22C16284748780-1ab0e2407-3494-f274-e053-dbdaa90a6471These 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
0115-9920-01Dexmethylphenidate hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-9920-01EA - Each0115-99203225d0a8-df27-4a93-9c19-3c05dfa7b0ab12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-9920DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Current NDC, Legacy NDC, 1 package rows20231122_93e56455-0f15-4ed9-a63a-7fbd0697d520.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899439dexmethylphenidate HCl 10 MG 24HR Extended Release Oral CapsulePSN93e56455-0f15-4ed9-a63a-7fbd0697d52015
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSN93e56455-0f15-4ed9-a63a-7fbd0697d52015
899485dexmethylphenidate HCl 20 MG 24HR Extended Release Oral CapsulePSN93e56455-0f15-4ed9-a63a-7fbd0697d52015
899495dexmethylphenidate HCl 30 MG 24HR Extended Release Oral CapsulePSN93e56455-0f15-4ed9-a63a-7fbd0697d52015
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSN93e56455-0f15-4ed9-a63a-7fbd0697d52015
89943924 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCD93e56455-0f15-4ed9-a63a-7fbd0697d52015
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCD93e56455-0f15-4ed9-a63a-7fbd0697d52015
89948524 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCD93e56455-0f15-4ed9-a63a-7fbd0697d52015
89949524 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD93e56455-0f15-4ed9-a63a-7fbd0697d52015
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCD93e56455-0f15-4ed9-a63a-7fbd0697d52015
899439dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral CapsuleSY93e56455-0f15-4ed9-a63a-7fbd0697d52015
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSY93e56455-0f15-4ed9-a63a-7fbd0697d52015
899485dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral CapsuleSY93e56455-0f15-4ed9-a63a-7fbd0697d52015
899495dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY93e56455-0f15-4ed9-a63a-7fbd0697d52015
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSY93e56455-0f15-4ed9-a63a-7fbd0697d52015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-9920-0100115992001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-9920-01) 2014-11-110000-00-00NoNoCurrent