oxymorphone hydrochloride

Generic: oxymorphone hydrochloride

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

Drug Facts

Product Profile

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

oxymorphone hydrochloride 10 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0284
Product ID 0054-0284_74519e3e-078f-42ea-882e-1df0eb0eaaee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090964
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2010-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540284
Hyphenated Format 0054-0284

Supplemental Identifiers

RxCUI
977939 977942
UNII
5Y2EI94NBC

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 oxymorphone hydrochloride (source: ndc)
Generic Name oxymorphone hydrochloride (source: ndc)
Application Number ANDA090964 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0054-0284-25)
source: ndc

Packages (1)

0054-0284-25 100 TABLET in 1 BOTTLE (0054-0284-25)

Ingredients (1)

oxymorphone hydrochloride (10 mg/1)

Linked Drug Pages (1)

Oxymorphone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "74519e3e-078f-42ea-882e-1df0eb0eaaee", "openfda": {"unii": ["5Y2EI94NBC"], "rxcui": ["977939", "977942"], "spl_set_id": ["3eb971cf-ab82-49f3-a46c-4d76a8ce599e"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0054-0284-25)", "package_ndc": "0054-0284-25", "marketing_start_date": "20100927"}], "brand_name": "Oxymorphone Hydrochloride", "product_id": "0054-0284_74519e3e-078f-42ea-882e-1df0eb0eaaee", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-0284", "dea_schedule": "CII", "generic_name": "oxymorphone hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxymorphone Hydrochloride", "active_ingredients": [{"name": "OXYMORPHONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090964", "marketing_category": "ANDA", "marketing_start_date": "20100927", "listing_expiration_date": "20261231"}