Methadone Hydrochloride
These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for . METHADONE HYDROCHLORIDE oral concentrate, CII Initial U.S. Approval: 1947
Approved
Approval ID
d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
VistaPharm, LLC
DUNS: 116743084
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methadone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66689-694
Application NumberANDA040088
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methadone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2024
FDA Product Classification
INGREDIENTS (10)
METHADONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 229809935B
Classification: ACTIB
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Methadone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66689-695
Application NumberANDA040088
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methadone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2024
FDA Product Classification
INGREDIENTS (4)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
METHADONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 229809935B
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT