methadone hydrochloride

Generic: methadone hydrochloride

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

Drug Facts

Product Profile

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

methadone hydrochloride 5 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0709
Product ID 0054-0709_32014633-5c89-4163-9fa7-239777c04d1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088109
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 1983-03-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540709
Hyphenated Format 0054-0709

Supplemental Identifiers

RxCUI
864706 864718
UPC
0300540709259 0300540710255
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 ANDA088109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0054-0709-20) / 100 TABLET in 1 BLISTER PACK
  • 100 TABLET in 1 BOTTLE, PLASTIC (0054-0709-25)
source: ndc

Packages (2)

0054-0709-20 1 BLISTER PACK in 1 CARTON (0054-0709-20) / 100 TABLET in 1 BLISTER PACK 0054-0709-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-0709-25)

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": "32014633-5c89-4163-9fa7-239777c04d1d", "openfda": {"upc": ["0300540709259", "0300540710255"], "unii": ["229809935B"], "rxcui": ["864706", "864718"], "spl_set_id": ["50f14803-78c0-4d19-8b5d-9a9c17582ac1"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0054-0709-20)  / 100 TABLET in 1 BLISTER PACK", "package_ndc": "0054-0709-20", "marketing_start_date": "19830308"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0054-0709-25)", "package_ndc": "0054-0709-25", "marketing_start_date": "19830308"}], "brand_name": "METHADONE HYDROCHLORIDE", "product_id": "0054-0709_32014633-5c89-4163-9fa7-239777c04d1d", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-0709", "dea_schedule": "CII", "generic_name": "METHADONE HYDROCHLORIDE", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHADONE HYDROCHLORIDE", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA088109", "marketing_category": "ANDA", "marketing_start_date": "19830308", "listing_expiration_date": "20271231"}