Dexmethylphenidate Hydrochloride

Product NDC
63629-2305
11-digit product format
636292305
Labeler code
63629
Product ID
63629-2305_a94ee633-3b2f-4f07-b250-f061c7d890e4
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
2.5 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 HYDROCHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899557

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
63629-2305-1Dexmethylphenidate Hydrochloride100 in 1 BOTTLE, PLASTICTABLET100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2305-1EA - Each63629-23052f67296d-65ae-4cd0-8c4b-131cd23f6d3c12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2305DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240112_194bb3a5-5f6c-49e3-85ab-ac557b3f8bbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899557dexmethylphenidate HCl 2.5 MG Oral TabletPSN194bb3a5-5f6c-49e3-85ab-ac557b3f8bbd103
899557dexmethylphenidate hydrochloride 2.5 MG Oral TabletSCD194bb3a5-5f6c-49e3-85ab-ac557b3f8bbd103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2305-163629230501100 TABLET in 1 BOTTLE, PLASTIC (63629-2305-1) 100 tablet2021-12-220000-00-00NoNoCurrent