MedPath
FDA Product

Methadone Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Methadone Hydrochloride

17856-0392

Regulatory Information

17856-0392

ANDA040180

C73584

September 14, 2022

USA

Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) Methadone Hydrochloride Oral Concentrate USP CII(Cherry) FOR ORAL USE ONLY Rx Only

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

047437707

Active Ingredients

METHADONE HYDROCHLORIDE

Quantity: 10 mg in 1 mL

Code: 229809935B

Class Code: ACTIB

Inactive Ingredients

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

D&C RED NO. 33

Code: 9DBA0SBB0L

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

CHERRY

Code: BUC5I9595W

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

METHADONE

Code: UC6VBE7V1Z

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