methadone hydrochloride

Generic: methadone hydrochloride

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

Drug Facts

Product Profile

Brand Name methadone hydrochloride
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 0406-4123
Product ID 0406-4123_f3e27571-1978-4639-a625-a7ff53e446d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207368
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-06-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04064123
Hyphenated Format 0406-4123

Supplemental Identifiers

RxCUI
991147
UPC
0304064123034
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 ANDA207368 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0406-4123-03) / 30 mL in 1 BOTTLE, DROPPER
  • 1000 mL in 1 BOTTLE (0406-4123-10)
source: ndc

Packages (2)

0406-4123-03 1 BOTTLE, DROPPER in 1 CARTON (0406-4123-03) / 30 mL in 1 BOTTLE, DROPPER 0406-4123-10 1000 mL in 1 BOTTLE (0406-4123-10)

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": "f3e27571-1978-4639-a625-a7ff53e446d6", "openfda": {"upc": ["0304064123034"], "unii": ["229809935B"], "rxcui": ["991147"], "spl_set_id": ["14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab58"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0406-4123-03)  / 30 mL in 1 BOTTLE, DROPPER", "package_ndc": "0406-4123-03", "marketing_start_date": "20210618"}, {"sample": false, "description": "1000 mL in 1 BOTTLE (0406-4123-10)", "package_ndc": "0406-4123-10", "marketing_start_date": "20210618"}], "brand_name": "Methadone Hydrochloride", "product_id": "0406-4123_f3e27571-1978-4639-a625-a7ff53e446d6", "dosage_form": "CONCENTRATE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-4123", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA207368", "marketing_category": "ANDA", "marketing_start_date": "20210618", "listing_expiration_date": "20261231"}