methadose dispersible

Generic: methadone hydrochloride

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadose dispersible
Generic Name methadone hydrochloride
Labeler specgx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methadone hydrochloride 40 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-0540
Product ID 0406-0540_991d6748-896f-42c1-88d6-fe1e77275181
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074184
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 1993-04-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04060540
Hyphenated Format 0406-0540

Supplemental Identifiers

RxCUI
864978 864980
UPC
0304060540347 0304062540017
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 methadose dispersible (source: ndc)
Generic Name methadone hydrochloride (source: ndc)
Application Number ANDA074184 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-0540-34)
source: ndc

Packages (1)

0406-0540-34 100 TABLET in 1 BOTTLE (0406-0540-34)

Ingredients (1)

methadone hydrochloride (40 mg/1)

Linked Drug Pages (1)

METHADOSE DISPERSIBLE, METHADONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "991d6748-896f-42c1-88d6-fe1e77275181", "openfda": {"upc": ["0304060540347", "0304062540017"], "unii": ["229809935B"], "rxcui": ["864978", "864980"], "spl_set_id": ["544483e6-6f9d-4371-9e93-313e54e0ea05"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-0540-34)", "package_ndc": "0406-0540-34", "marketing_start_date": "19930429"}], "brand_name": "METHADOSE DISPERSIBLE", "product_id": "0406-0540_991d6748-896f-42c1-88d6-fe1e77275181", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-0540", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHADOSE DISPERSIBLE", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA074184", "marketing_category": "ANDA", "marketing_start_date": "19930429", "listing_expiration_date": "20261231"}