Dexmethylphenidate hydrochloride

Product NDC
72162-2427
11-digit product format
721622427
Labeler code
72162
Product ID
72162-2427_b5f9c9d0-c4db-4a1d-a449-8dc8a549c114
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
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899548

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
72162-2427-1Dexmethylphenidate hydrochloride100 in 1 BOTTLETABLET100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2427-1EA - Each72162-24277b89ae62-2bd2-4421-8ed4-01525ccdd9e912025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2427DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20241120_76aa2130-2b7b-40f7-a35a-d51b21da4636.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899548dexmethylphenidate HCl 10 MG Oral TabletPSN76aa2130-2b7b-40f7-a35a-d51b21da4636101
899548dexmethylphenidate hydrochloride 10 MG Oral TabletSCD76aa2130-2b7b-40f7-a35a-d51b21da4636101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2427-172162242701100 TABLET in 1 BOTTLE (72162-2427-1) 100 tablet2026-03-17NoNoHistorical