Dexmethylphenidate Hydrochloride
These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001
Approved
Approval ID
194bb3a5-5f6c-49e3-85ab-ac557b3f8bbd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-2305
Application NumberANDA207901
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2021
FDA Product Classification
INGREDIENTS (6)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT