FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
72162-1496
11-digit product format
721621496
Labeler code
72162
Product ID
72162-1496_9358f9d6-e069-48ff-b646-99f47d35464c
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
35 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 HYDROCHLORIDE35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui1101932

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
72162-1496-1Dexmethylphenidate Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1496-1EA - Each72162-149617ad7cb5-57c8-4eec-bb86-4dbd7630313612023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1496DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20240829_b7410d65-9c7f-4ffd-b957-969e2725f38f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101932dexmethylphenidate HCl 35 MG 24HR Extended Release Oral CapsulePSNb7410d65-9c7f-4ffd-b957-969e2725f38f102
110193224 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral CapsuleSCDb7410d65-9c7f-4ffd-b957-969e2725f38f102
1101932dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral CapsuleSYb7410d65-9c7f-4ffd-b957-969e2725f38f102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1496-172162149601100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1496-1) 2024-08-12NoNoHistorical