methadone hydrochloride

Generic: methadone hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

methadone hydrochloride 10 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-217
Product ID 67457-217_868dd5b8-2e28-475c-b6c3-bfc0a33fb793
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021624
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2012-12-20

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457217
Hyphenated Format 67457-217

Supplemental Identifiers

RxCUI
864714
UNII
229809935B

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methadone hydrochloride (source: ndc)
Generic Name methadone hydrochloride (source: ndc)
Application Number NDA021624 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (67457-217-20) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

67457-217-20 1 VIAL, MULTI-DOSE in 1 CARTON (67457-217-20) / 20 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

methadone hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Methadone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "868dd5b8-2e28-475c-b6c3-bfc0a33fb793", "openfda": {"unii": ["229809935B"], "rxcui": ["864714"], "spl_set_id": ["092d78eb-6423-495c-bf0d-e6532bea7138"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (67457-217-20)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "67457-217-20", "marketing_start_date": "20121220"}], "brand_name": "Methadone Hydrochloride", "product_id": "67457-217_868dd5b8-2e28-475c-b6c3-bfc0a33fb793", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "67457-217", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "NDA021624", "marketing_category": "NDA", "marketing_start_date": "20121220", "listing_expiration_date": "20261231"}