methadone hydrochloride

Generic: methadone hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methadone hydrochloride 10 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-318
Product ID 42806-318_43485290-cdfc-4126-a615-c52745fcd68b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090065
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-06-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806318
Hyphenated Format 42806-318

Supplemental Identifiers

RxCUI
864706 864718
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 ANDA090065 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42806-318-01)
source: ndc

Packages (1)

42806-318-01 100 TABLET in 1 BOTTLE (42806-318-01)

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": "43485290-cdfc-4126-a615-c52745fcd68b", "openfda": {"unii": ["229809935B"], "rxcui": ["864706", "864718"], "spl_set_id": ["6da7501b-b881-4bc7-891a-74214a00a3ac"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42806-318-01)", "package_ndc": "42806-318-01", "marketing_start_date": "20180611"}], "brand_name": "Methadone Hydrochloride", "product_id": "42806-318_43485290-cdfc-4126-a615-c52745fcd68b", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "42806-318", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090065", "marketing_category": "ANDA", "marketing_start_date": "20180611", "listing_expiration_date": "20261231"}