diskets

Generic: methadone hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name diskets
Generic Name methadone hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methadone hydrochloride 40 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-4538
Product ID 0054-4538_c64401ed-ad61-4d03-b1b8-4e0cb426f911
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017058
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 1973-03-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00544538
Hyphenated Format 0054-4538

Supplemental Identifiers

RxCUI
864978 1990745
UPC
0300544538251
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 diskets (source: ndc)
Generic Name methadone hydrochloride (source: ndc)
Application Number NDA017058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0054-4538-25)
source: ndc

Packages (1)

0054-4538-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-4538-25)

Ingredients (1)

methadone hydrochloride (40 mg/1)

Linked Drug Pages (1)

DISKETS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c64401ed-ad61-4d03-b1b8-4e0cb426f911", "openfda": {"upc": ["0300544538251"], "unii": ["229809935B"], "rxcui": ["864978", "1990745"], "spl_set_id": ["e6af84de-cbfc-4a3b-bd73-6bcf77337168"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0054-4538-25)", "package_ndc": "0054-4538-25", "marketing_start_date": "19730314"}], "brand_name": "DISKETS", "product_id": "0054-4538_c64401ed-ad61-4d03-b1b8-4e0cb426f911", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-4538", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DISKETS", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "NDA017058", "marketing_category": "NDA", "marketing_start_date": "19730314", "listing_expiration_date": "20271231"}