Methylphenidate Hydrochloride
Methylphenidate HCl Chewable Tablet, CIIRx only
Approved
Approval ID
91833146-fa95-471a-8b8d-6d36a2db5c9a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2023
Manufacturers
FDA
XLCare Pharmaceuticals, Inc.
DUNS: 080991142
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methylphenidate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-127
Application NumberANDA210354
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (7)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Methylphenidate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-125
Application NumberANDA210354
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (7)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
Methylphenidate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-126
Application NumberANDA210354
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (7)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT