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FDA Approval

Dexmethylphenidate Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Lannett Company, Inc.
DUNS: 002277481
Effective Date
July 26, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dexmethylphenidate(2.5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Lannett Company, Inc.

Lannett Company, Inc.

006422406

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dexmethylphenidate Hydrochloride

Product Details

NDC Product Code
0527-1899
Application Number
ANDA209468
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 27, 2023
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
DexmethylphenidateActive
Code: 1678OK0E08Class: ACTIBQuantity: 2.5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Dexmethylphenidate Hydrochloride

Product Details

NDC Product Code
0527-1900
Application Number
ANDA209468
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 27, 2023
DexmethylphenidateActive
Code: 1678OK0E08Class: ACTIBQuantity: 5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT

Dexmethylphenidate Hydrochloride

Product Details

NDC Product Code
0527-1901
Application Number
ANDA209468
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 27, 2023
DexmethylphenidateActive
Code: 1678OK0E08Class: ACTIBQuantity: 10 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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