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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
Precision Dose, Inc.
DUNS: 035886746
Effective Date
November 17, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Methadone(5 mg in 5 mL)

Products1

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
68094-331
Application Number
ANDA087393
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 30, 2023
MethadoneActive
Code: 229809935BClass: ACTIBQuantity: 5 mg in 5 mL
BENZOIC ACIDInactive
Code: 8SKN0B0MIMClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
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