FDA.reportPublic FDA data

Dexmethylphenidate hydrochloride

Product NDC
57664-378
11-digit product format
576640378
Labeler code
57664
Product ID
57664-378_0d0cbfc3-ae27-b481-e063-6394a90a917c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA201231
Marketing category
ANDA
Marketing start
2013-09-26
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
Rxcui899518, 899548, 899557

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-378-08Dexmethylphenidate hydrochloride100 in 1 BOTTLETABLET10013
57664-378-13Dexmethylphenidate hydrochloride500 in 1 BOTTLETABLET50013
57664-378-18Dexmethylphenidate hydrochloride1000 in 1 BOTTLETABLET100013
57664-378-83Dexmethylphenidate hydrochloride30 in 1 BOTTLETABLET3013
57664-378-88Dexmethylphenidate hydrochloride100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-378-88EA - Each57664-37831e13c92-57ec-475e-9cca-ff6845b389d312015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]5
DEXMETHYLPHENIDATEACTIVE MOIETYM32RH9MFGPDEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UDEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-378DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]13Current NDC, Legacy NDC, 5 package rows20240105_987b4983-1edc-40f1-adc9-724747080969.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899548dexmethylphenidate HCl 10 MG Oral TabletPSN987b4983-1edc-40f1-adc9-72474708096913
899557dexmethylphenidate HCl 2.5 MG Oral TabletPSN987b4983-1edc-40f1-adc9-72474708096913
899518dexmethylphenidate HCl 5 MG Oral TabletPSN987b4983-1edc-40f1-adc9-72474708096913
899548dexmethylphenidate hydrochloride 10 MG Oral TabletSCD987b4983-1edc-40f1-adc9-72474708096913
899557dexmethylphenidate hydrochloride 2.5 MG Oral TabletSCD987b4983-1edc-40f1-adc9-72474708096913
899518dexmethylphenidate hydrochloride 5 MG Oral TabletSCD987b4983-1edc-40f1-adc9-72474708096913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-378-0857664037808100 TABLET in 1 BOTTLE (57664-378-08) 100 tablet2013-09-260000-00-00NoNoCurrent
57664-378-1357664037813500 TABLET in 1 BOTTLE (57664-378-13) 500 tablet2013-09-260000-00-00NoNoCurrent
57664-378-18576640378181000 TABLET in 1 BOTTLE (57664-378-18) 1000 tablet2013-09-260000-00-00NoNoCurrent
57664-378-835766403788330 TABLET in 1 BOTTLE (57664-378-83) 30 tablet2013-09-260000-00-00NoNoCurrent
57664-378-8857664037888100 TABLET in 1 BOTTLE (57664-378-88) 100 tablet2013-09-260000-00-00NoNoCurrent