methadone hydrochloride

Generic: methadone hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

methadone hydrochloride 10 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6266
Product ID 0641-6266_821743df-67de-46a9-92c5-b530047a3192
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218609
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2025-06-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416266
Hyphenated Format 0641-6266

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 ANDA218609 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0641-6266-01) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0641-6266-01 1 VIAL, MULTI-DOSE in 1 CARTON (0641-6266-01) / 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": "821743df-67de-46a9-92c5-b530047a3192", "openfda": {"unii": ["229809935B"], "rxcui": ["864714"], "spl_set_id": ["1a6dbcb0-68f2-4f8b-94ee-baa2aa296293"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0641-6266-01)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0641-6266-01", "marketing_start_date": "20250612"}], "brand_name": "Methadone Hydrochloride", "product_id": "0641-6266_821743df-67de-46a9-92c5-b530047a3192", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6266", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA218609", "marketing_category": "ANDA", "marketing_start_date": "20250612", "listing_expiration_date": "20261231"}