methadone hydrocloride dye-free, sugar-free, unflavored

Generic: methadone hydrochloride

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

Drug Facts

Product Profile

Brand Name methadone hydrocloride dye-free, sugar-free, unflavored
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 0527-1927
Product ID 0527-1927_127a6533-e403-48b1-9592-5a90d5cf155e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212093
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2020-11-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05271927
Hyphenated Format 0527-1927

Supplemental Identifiers

RxCUI
991147
UPC
0305271927361
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 dye-free, sugar-free, unflavored (source: ndc)
Generic Name methadone hydrochloride (source: ndc)
Application Number ANDA212093 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0527-1927-36) / 30 mL in 1 BOTTLE, PLASTIC
  • 1000 mL in 1 BOTTLE, PLASTIC (0527-1927-39)
source: ndc

Packages (2)

0527-1927-36 1 BOTTLE, PLASTIC in 1 CARTON (0527-1927-36) / 30 mL in 1 BOTTLE, PLASTIC 0527-1927-39 1000 mL in 1 BOTTLE, PLASTIC (0527-1927-39)

Ingredients (1)

methadone hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Methadone Hydrocloride dye-free, sugar-free, unflavored ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "127a6533-e403-48b1-9592-5a90d5cf155e", "openfda": {"upc": ["0305271927361"], "unii": ["229809935B"], "rxcui": ["991147"], "spl_set_id": ["0955ea4a-c6b8-431f-ba42-9641b5b102ea"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0527-1927-36)  / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0527-1927-36", "marketing_start_date": "20201102"}, {"sample": false, "description": "1000 mL in 1 BOTTLE, PLASTIC (0527-1927-39)", "package_ndc": "0527-1927-39", "marketing_start_date": "20201102"}], "brand_name": "Methadone Hydrocloride dye-free, sugar-free, unflavored", "product_id": "0527-1927_127a6533-e403-48b1-9592-5a90d5cf155e", "dosage_form": "CONCENTRATE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0527-1927", "dea_schedule": "CII", "generic_name": "methadone hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrocloride", "brand_name_suffix": "dye-free, sugar-free, unflavored", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA212093", "marketing_category": "ANDA", "marketing_start_date": "20201102", "listing_expiration_date": "20271231"}