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 SOLUTION
Routes
ORAL
Active Ingredients

methadone hydrochloride 10 mg/5mL

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-6221
Product ID 0406-6221_56ffbe46-c151-4fe4-af5d-c408311c261f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207537
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 04066221
Hyphenated Format 0406-6221

Supplemental Identifiers

RxCUI
864761 864769
UPC
0304066221059 0304066225057
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 ANDA207537 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (0406-6221-05)
source: ndc

Packages (1)

0406-6221-05 500 mL in 1 BOTTLE (0406-6221-05)

Ingredients (1)

methadone hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

METHADONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "56ffbe46-c151-4fe4-af5d-c408311c261f", "openfda": {"upc": ["0304066221059", "0304066225057"], "unii": ["229809935B"], "rxcui": ["864761", "864769"], "spl_set_id": ["5baef1bf-8bf0-429c-a4ce-1c93171f3f15"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (0406-6221-05)", "package_ndc": "0406-6221-05", "marketing_start_date": "20210618"}], "brand_name": "METHADONE HYDROCHLORIDE", "product_id": "0406-6221_56ffbe46-c151-4fe4-af5d-c408311c261f", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-6221", "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/5mL"}], "application_number": "ANDA207537", "marketing_category": "ANDA", "marketing_start_date": "20210618", "listing_expiration_date": "20261231"}