Dexmethylphenidate hydrochloride

Product NDC
72162-2426
11-digit product format
721622426
Labeler code
72162
Product ID
72162-2426_a1d50a79-cde0-4b17-949c-a422bb7cbc57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209211
Marketing category
ANDA
Marketing start
2024-05-03
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
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 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
72162-2426-1Dexmethylphenidate hydrochloride100 in 1 BOTTLETABLET100101
72162-2426-6Dexmethylphenidate hydrochloride60 in 1 BOTTLETABLET60101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2426-1EA - Each72162-24269d4dcf1b-3434-47c4-b71b-532861108d5312025-01-14
72162-2426-6EA - Each72162-2426c17ba4a6-d216-499d-b87b-b5c3d2a10a5b12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2426DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20241120_90308fd0-d174-4979-aa22-16290d6cc5bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899518dexmethylphenidate HCl 5 MG Oral TabletPSN90308fd0-d174-4979-aa22-16290d6cc5bb101
899518dexmethylphenidate hydrochloride 5 MG Oral TabletSCD90308fd0-d174-4979-aa22-16290d6cc5bb101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2426-172162242601100 TABLET in 1 BOTTLE (72162-2426-1) 100 tablet2026-03-17NoNoHistorical
72162-2426-67216224260660 TABLET in 1 BOTTLE (72162-2426-6) 60 tablet2026-03-17NoNoHistorical