Methylphenidate HCl
Methylphenidate HCl Oral Solution
Approved
Approval ID
7d66dbf9-3966-4949-b7c9-d2ca8c7f3278
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 22, 2020
Manufacturers
FDA
Patrin Pharma, Inc.
DUNS: 806841677
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methylphenidate HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39328-054
Application NumberANDA210764
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylphenidate HCl
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2020
FDA Product Classification
INGREDIENTS (6)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: 4B3SC438HI
Classification: ACTIB
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Methylphenidate HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39328-154
Application NumberANDA210764
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylphenidate HCl
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2020
FDA Product Classification
INGREDIENTS (6)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 10 mg in 5 mL
Code: 4B3SC438HI
Classification: ACTIB
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT