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FDA Approval

Methadone Hydrochloride

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

FDA Approval Summary

Company
VistaPharm, LLC
DUNS: 116743084
Effective Date
January 25, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Methadone(10 mg in 1 mL)

Products2

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

Methadone Hydrochloride

Product Details

NDC Product Code
66689-694
Application Number
ANDA040088
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 26, 2024
MethadoneActive
Code: 229809935BClass: ACTIBQuantity: 10 mg in 1 mL
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT

Methadone Hydrochloride

Product Details

NDC Product Code
66689-695
Application Number
ANDA040088
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 26, 2024
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
MethadoneActive
Code: 229809935BClass: ACTIBQuantity: 10 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
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