Dexmethylphenidate Hydrochloride

Product NDC
63629-2306
11-digit product format
636292306
Labeler code
63629
Product ID
63629-2306_f57fb8f5-b162-4b9d-a4be-0cfc085bf5ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmethylphenidate hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207901
Marketing category
ANDA
Marketing start
2001-11-30
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

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
63629-2306-1Dexmethylphenidate Hydrochloride100 in 1 BOTTLE, PLASTICTABLET100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2306-1EA - Each63629-23062653bca7-87c2-4f6d-95f3-a6f012a6bc6512021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2306DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240607_f930af78-760b-42c7-af30-ffcc64c4d35d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899518dexmethylphenidate HCl 5 MG Oral TabletPSNf930af78-760b-42c7-af30-ffcc64c4d35d104
899518dexmethylphenidate hydrochloride 5 MG Oral TabletSCDf930af78-760b-42c7-af30-ffcc64c4d35d104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2306-163629230601100 TABLET in 1 BOTTLE, PLASTIC (63629-2306-1) 100 tablet2021-12-220000-00-00NoNoCurrent