FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
72162-1493
11-digit product format
721621493
Labeler code
72162
Product ID
72162-1493_36435a90-5e2f-496b-b2aa-fb71730dd580
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202842
Marketing category
ANDA
Marketing start
2017-01-05
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui1101926

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
72162-1493-1Dexmethylphenidate Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1493-1EA - Each72162-1493d7880d4a-4907-4b6c-ab49-3fae09d69ae112023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1493DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20240829_d9c450fa-c8c5-4ff0-a263-4a9eee6f5437.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101926dexmethylphenidate HCl 25 MG 24HR Extended Release Oral CapsulePSNd9c450fa-c8c5-4ff0-a263-4a9eee6f5437102
110192624 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral CapsuleSCDd9c450fa-c8c5-4ff0-a263-4a9eee6f5437102
1101926dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral CapsuleSYd9c450fa-c8c5-4ff0-a263-4a9eee6f5437102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1493-172162149301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1493-1) 2024-08-12NoNoHistorical