methadone hydrocloride

Generic: methadone hydrochloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrocloride
Generic Name methadone hydrochloride
Labeler lannett company, inc.
Dosage Form CONCENTRATE
Routes
ORAL
Active Ingredients

methadone hydrochloride 10 mg/mL

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-1926
Product ID 0527-1926_6714ab49-287c-460f-84c6-4a2eb909b896
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212094
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-03-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05271926
Hyphenated Format 0527-1926

Supplemental Identifiers

RxCUI
991147
UPC
0305271926395
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 hydrocloride (source: ndc)
Generic Name methadone hydrochloride (source: ndc)
Application Number ANDA212094 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0527-1926-36) / 30 mL in 1 BOTTLE, PLASTIC
  • 1000 mL in 1 BOTTLE, PLASTIC (0527-1926-39)
source: ndc

Packages (2)

0527-1926-36 1 BOTTLE, PLASTIC in 1 CARTON (0527-1926-36) / 30 mL in 1 BOTTLE, PLASTIC 0527-1926-39 1000 mL in 1 BOTTLE, PLASTIC (0527-1926-39)

Ingredients (1)

methadone hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Methadone Hydrocloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6714ab49-287c-460f-84c6-4a2eb909b896", "openfda": {"upc": ["0305271926395"], "unii": ["229809935B"], "rxcui": ["991147"], "spl_set_id": ["119da5aa-bb8a-47cc-afb6-bcd2040a92a3"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0527-1926-36)  / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0527-1926-36", "marketing_start_date": "20210303"}, {"sample": false, "description": "1000 mL in 1 BOTTLE, PLASTIC (0527-1926-39)", "package_ndc": "0527-1926-39", "marketing_start_date": "20210303"}], "brand_name": "Methadone Hydrocloride", "product_id": "0527-1926_6714ab49-287c-460f-84c6-4a2eb909b896", "dosage_form": "CONCENTRATE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0527-1926", "dea_schedule": "CII", "generic_name": "methadone hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrocloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA212094", "marketing_category": "ANDA", "marketing_start_date": "20210303", "listing_expiration_date": "20261231"}