methadone hydrochloride

Generic: methadone hydrochloride

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

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler hikma pharmaceuticals usa
Dosage Form CONCENTRATE
Routes
ORAL
Active Ingredients

methadone hydrochloride 10 mg/mL

Manufacturer
Hikma Pharmaceuticals USA

Identifiers & Regulatory

Product NDC 0054-0392
Product ID 0054-0392_2b59a769-5e79-4372-8dbd-3ae4e7d56d07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040180
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2010-03-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540392
Hyphenated Format 0054-0392

Supplemental Identifiers

RxCUI
991147
UPC
0300540391683 0300540392680
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 ANDA040180 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1000 mL in 1 BOTTLE (0054-0392-68)
source: ndc

Packages (1)

0054-0392-68 1000 mL in 1 BOTTLE (0054-0392-68)

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": ["ORAL"], "spl_id": "2b59a769-5e79-4372-8dbd-3ae4e7d56d07", "openfda": {"upc": ["0300540391683", "0300540392680"], "unii": ["229809935B"], "rxcui": ["991147"], "spl_set_id": ["e72841bf-364b-49b1-8e69-7e26ddcd2657"], "manufacturer_name": ["Hikma Pharmaceuticals USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 mL in 1 BOTTLE (0054-0392-68)", "package_ndc": "0054-0392-68", "marketing_start_date": "20100316"}], "brand_name": "Methadone Hydrochloride", "product_id": "0054-0392_2b59a769-5e79-4372-8dbd-3ae4e7d56d07", "dosage_form": "CONCENTRATE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-0392", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA040180", "marketing_category": "ANDA", "marketing_start_date": "20100316", "listing_expiration_date": "20261231"}