methadone hydrochloride

Generic: methadone hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methadone hydrochloride 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7417
Product ID 0904-7417_51c895c4-90fb-4d88-9032-beea257bec6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088109
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-01-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047417
Hyphenated Format 0904-7417

Supplemental Identifiers

RxCUI
864706
UNII
229809935B

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 ANDA088109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7417-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7417-61 100 BLISTER PACK in 1 CARTON (0904-7417-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

methadone hydrochloride (10 mg/1)

Linked Drug Pages (1)

METHADONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "51c895c4-90fb-4d88-9032-beea257bec6c", "openfda": {"unii": ["229809935B"], "rxcui": ["864706"], "spl_set_id": ["db52fdc0-765a-4fad-a8f9-ef98c6e4b898"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7417-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7417-61", "marketing_start_date": "20240103"}], "brand_name": "METHADONE HYDROCHLORIDE", "product_id": "0904-7417_51c895c4-90fb-4d88-9032-beea257bec6c", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0904-7417", "dea_schedule": "CII", "generic_name": "METHADONE HYDROCHLORIDE", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHADONE HYDROCHLORIDE", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA088109", "marketing_category": "ANDA", "marketing_start_date": "20240103", "listing_expiration_date": "20261231"}