oxymorphone hydrochloride

Generic: oxymorphone hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxymorphone hydrochloride
Generic Name oxymorphone hydrochloride
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxymorphone hydrochloride 10 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-331
Product ID 42806-331_8a01b8b5-5114-46e2-9949-1ab6beb78d81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201187
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806331
Hyphenated Format 42806-331

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 ANDA201187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42806-331-01)
source: ndc

Packages (1)

42806-331-01 100 TABLET in 1 BOTTLE (42806-331-01)

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": "8a01b8b5-5114-46e2-9949-1ab6beb78d81", "openfda": {"unii": ["5Y2EI94NBC"], "rxcui": ["977939", "977942"], "spl_set_id": ["95804e72-232d-425d-b23d-a66f43bdf0c6"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42806-331-01)", "package_ndc": "42806-331-01", "marketing_start_date": "20190515"}], "brand_name": "Oxymorphone Hydrochloride", "product_id": "42806-331_8a01b8b5-5114-46e2-9949-1ab6beb78d81", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "42806-331", "dea_schedule": "CII", "generic_name": "Oxymorphone Hydrochloride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxymorphone Hydrochloride", "active_ingredients": [{"name": "OXYMORPHONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA201187", "marketing_category": "ANDA", "marketing_start_date": "20190515", "listing_expiration_date": "20261231"}