methadose

Generic: methadone hydrochloride

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadose
Generic Name methadone hydrochloride
Labeler specgx llc
Dosage Form CONCENTRATE
Routes
ORAL
Active Ingredients

methadone hydrochloride 10 mg/mL

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-0527
Product ID 0406-0527_1d37bef9-02d8-4da4-b01e-6eec35380ed6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017116
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 1973-03-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04060527
Hyphenated Format 0406-0527

Supplemental Identifiers

RxCUI
991147 991149
UPC
0304068725104 0304060527102
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 methadose (source: ndc)
Generic Name methadone hydrochloride (source: ndc)
Application Number NDA017116 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1000 mL in 1 BOTTLE, PLASTIC (0406-0527-10)
source: ndc

Packages (1)

0406-0527-10 1000 mL in 1 BOTTLE, PLASTIC (0406-0527-10)

Ingredients (1)

methadone hydrochloride (10 mg/mL)

Linked Drug Pages (1)

METHADOSE, METHADOSE SUGAR-FREE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1d37bef9-02d8-4da4-b01e-6eec35380ed6", "openfda": {"upc": ["0304068725104", "0304060527102"], "unii": ["229809935B"], "rxcui": ["991147", "991149"], "spl_set_id": ["808a9d0b-720b-4034-a862-5122ff514608"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 mL in 1 BOTTLE, PLASTIC (0406-0527-10)", "package_ndc": "0406-0527-10", "marketing_start_date": "19730314"}], "brand_name": "METHADOSE", "product_id": "0406-0527_1d37bef9-02d8-4da4-b01e-6eec35380ed6", "dosage_form": "CONCENTRATE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-0527", "dea_schedule": "CII", "generic_name": "methadone hydrochloride", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHADOSE", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "NDA017116", "marketing_category": "NDA", "marketing_start_date": "19730314", "listing_expiration_date": "20261231"}