methadone hydrochloride

Generic: methadone hydrochloride

Labeler: elite laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler elite laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methadone hydrochloride 5 mg/1

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-603
Product ID 64850-603_6745a13f-b53a-4f0d-9c0a-bbef6343a8d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210484
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-08-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64850603
Hyphenated Format 64850-603

Supplemental Identifiers

RxCUI
864706 864718
UPC
0364850603010 0364850604017
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 ANDA210484 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (64850-603-01)
source: ndc

Packages (1)

64850-603-01 100 TABLET in 1 BOTTLE, PLASTIC (64850-603-01)

Ingredients (1)

methadone hydrochloride (5 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": "6745a13f-b53a-4f0d-9c0a-bbef6343a8d3", "openfda": {"upc": ["0364850603010", "0364850604017"], "unii": ["229809935B"], "rxcui": ["864706", "864718"], "spl_set_id": ["d702d32b-98b1-412d-934c-1cd96af4b95a"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (64850-603-01)", "package_ndc": "64850-603-01", "marketing_start_date": "20180806"}], "brand_name": "Methadone Hydrochloride", "product_id": "64850-603_6745a13f-b53a-4f0d-9c0a-bbef6343a8d3", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "64850-603", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "Elite Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA210484", "marketing_category": "ANDA", "marketing_start_date": "20180806", "listing_expiration_date": "20261231"}