MedPath

METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE

Approved
Approval ID

af2fa7bc-5d43-47d8-835e-b9adc565600a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 6, 2016

Manufacturers
FDA

DIRECT RX

DUNS: 079254320

Products 1

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 Code61919-670
Application NumberNDA006134
Product Classification
M
Marketing Category
C73594
G
Generic Name
METHADONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2016
FDA Product Classification

INGREDIENTS (4)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHADONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 229809935B
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

METHADONE HYDROCHLORIDE - FDA Drug Approval Details