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 CONCENTRATE
Routes
ORAL
Active Ingredients

methadone hydrochloride 10 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3553
Product ID 0054-3553_f4843a89-4cfb-40de-8399-a7449b4865e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089897
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 1988-09-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00543553
Hyphenated Format 0054-3553

Supplemental Identifiers

RxCUI
991147
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 ANDA089897 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0054-3553-44) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

0054-3553-44 1 BOTTLE in 1 CARTON (0054-3553-44) / 30 mL in 1 BOTTLE

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": "f4843a89-4cfb-40de-8399-a7449b4865e2", "openfda": {"unii": ["229809935B"], "rxcui": ["991147"], "spl_set_id": ["d0e6a966-179a-45e0-8444-4c1b8523f8d2"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0054-3553-44)  / 30 mL in 1 BOTTLE", "package_ndc": "0054-3553-44", "marketing_start_date": "19880906"}], "brand_name": "Methadone Hydrochloride", "product_id": "0054-3553_f4843a89-4cfb-40de-8399-a7449b4865e2", "dosage_form": "CONCENTRATE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-3553", "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": "ANDA089897", "marketing_category": "ANDA", "marketing_start_date": "19880906", "listing_expiration_date": "20261231"}