FDA.reportPublic FDA data

Dexmethylphenidate Hydrochloride

Product NDC
27808-092
11-digit product format
278080092
Labeler code
27808
Product ID
27808-092_9e21f04a-b4b6-45b8-8da3-5955e6aa18a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmethylphenidate hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA207901
Marketing category
ANDA
Marketing start
2001-11-30
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
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1678OK0E08
Rxcui899518, 899548, 899557

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
27808-092-01Dexmethylphenidate Hydrochloride100 in 1 BOTTLETABLET10023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-092DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [CRANBURY PHARMACEUTICALS, LLC]23Current NDC, Legacy NDC, 1 package rows20250330_1f2aa66a-51dc-459c-a765-5364bccd310f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899518dexmethylphenidate HCl 5 MG Oral TabletPSNf930af78-760b-42c7-af30-ffcc64c4d35d104
899518dexmethylphenidate hydrochloride 5 MG Oral TabletSCDf930af78-760b-42c7-af30-ffcc64c4d35d104
899518dexmethylphenidate HCl 5 MG Oral TabletPSN17950616-ab96-4d7e-be48-f36cae547de0100
899518dexmethylphenidate hydrochloride 5 MG Oral TabletSCD17950616-ab96-4d7e-be48-f36cae547de0100
899548dexmethylphenidate HCl 10 MG Oral TabletPSN1f2aa66a-51dc-459c-a765-5364bccd310f23
899557dexmethylphenidate HCl 2.5 MG Oral TabletPSN1f2aa66a-51dc-459c-a765-5364bccd310f23
899518dexmethylphenidate HCl 5 MG Oral TabletPSN1f2aa66a-51dc-459c-a765-5364bccd310f23
899548dexmethylphenidate hydrochloride 10 MG Oral TabletSCD1f2aa66a-51dc-459c-a765-5364bccd310f23
899557dexmethylphenidate hydrochloride 2.5 MG Oral TabletSCD1f2aa66a-51dc-459c-a765-5364bccd310f23
899518dexmethylphenidate hydrochloride 5 MG Oral TabletSCD1f2aa66a-51dc-459c-a765-5364bccd310f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-092-0127808009201100 TABLET in 1 BOTTLE (27808-092-01) 100 tablet2001-11-300000-00-00NoNoCurrent