FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
0093-5553
11-digit product format
000935553
Labeler code
0093
Product ID
0093-5553_ee2dd90b-be3b-4649-b6f8-91468a37b1a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA078908
Marketing category
ANDA
Marketing start
2015-06-22
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-5553-01Dexmethylphenidate Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5553-01EA - Each0093-555333a17653-555d-4172-9202-fc6f47ba9c4d12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
DEXMETHYLPHENIDATEACTIVE MOIETYM32RH9MFGPDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
AMMONIO METHACRYLATE COPOLYMER TYPE BINACTIVE INGREDIENT161H3B14U2DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
GELATININACTIVE INGREDIENT2G86QN327LDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
SHELLACINACTIVE INGREDIENT46N107B71ODEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
SUCROSEINACTIVE INGREDIENTC151H8M554DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5553DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]21Current NDC, Legacy NDC, 1 package rows20250523_dd659d39-41f5-4612-8f17-bad602b4784d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899439dexmethylphenidate HCl 10 MG 24HR Extended Release Oral CapsulePSNdd659d39-41f5-4612-8f17-bad602b4784d23
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSNdd659d39-41f5-4612-8f17-bad602b4784d23
899485dexmethylphenidate HCl 20 MG 24HR Extended Release Oral CapsulePSNdd659d39-41f5-4612-8f17-bad602b4784d23
1101926dexmethylphenidate HCl 25 MG 24HR Extended Release Oral CapsulePSNdd659d39-41f5-4612-8f17-bad602b4784d23
899495dexmethylphenidate HCl 30 MG 24HR Extended Release Oral CapsulePSNdd659d39-41f5-4612-8f17-bad602b4784d23
1101932dexmethylphenidate HCl 35 MG 24HR Extended Release Oral CapsulePSNdd659d39-41f5-4612-8f17-bad602b4784d23
1006608dexmethylphenidate HCl 40 MG 24HR Extended Release Oral CapsulePSNdd659d39-41f5-4612-8f17-bad602b4784d23
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSNdd659d39-41f5-4612-8f17-bad602b4784d23
89943924 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCDdd659d39-41f5-4612-8f17-bad602b4784d23
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCDdd659d39-41f5-4612-8f17-bad602b4784d23
89948524 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDdd659d39-41f5-4612-8f17-bad602b4784d23
110192624 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral CapsuleSCDdd659d39-41f5-4612-8f17-bad602b4784d23
89949524 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCDdd659d39-41f5-4612-8f17-bad602b4784d23
110193224 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral CapsuleSCDdd659d39-41f5-4612-8f17-bad602b4784d23
100660824 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCDdd659d39-41f5-4612-8f17-bad602b4784d23
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCDdd659d39-41f5-4612-8f17-bad602b4784d23
899439dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral CapsuleSYdd659d39-41f5-4612-8f17-bad602b4784d23
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYdd659d39-41f5-4612-8f17-bad602b4784d23
899485dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral CapsuleSYdd659d39-41f5-4612-8f17-bad602b4784d23
1101926dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral CapsuleSYdd659d39-41f5-4612-8f17-bad602b4784d23
899495dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSYdd659d39-41f5-4612-8f17-bad602b4784d23
1101932dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral CapsuleSYdd659d39-41f5-4612-8f17-bad602b4784d23
1006608dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral CapsuleSYdd659d39-41f5-4612-8f17-bad602b4784d23
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSYdd659d39-41f5-4612-8f17-bad602b4784d23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5553-0100093555301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5553-01) 2015-06-220000-00-00NoNoCurrent