oxymorphone hydrochloride

Generic: oxymorphone hydrochloride

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

Drug Facts

Product Profile

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

oxymorphone hydrochloride 10 mg/1

Manufacturer
Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-104
Product ID 13107-104_6c5c7596-0b2c-435f-a619-706b4424370d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204459
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-04-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107104
Hyphenated Format 13107-104

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 ANDA204459 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13107-104-01)
  • 30 TABLET in 1 BOTTLE (13107-104-30)
  • 1000 TABLET in 1 BOTTLE (13107-104-99)
source: ndc

Packages (3)

13107-104-01 100 TABLET in 1 BOTTLE (13107-104-01) 13107-104-30 30 TABLET in 1 BOTTLE (13107-104-30) 13107-104-99 1000 TABLET in 1 BOTTLE (13107-104-99)

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": "6c5c7596-0b2c-435f-a619-706b4424370d", "openfda": {"unii": ["5Y2EI94NBC"], "rxcui": ["977939", "977942"], "spl_set_id": ["22c7652a-aa16-4fa8-89d9-517e69059068"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-104-01)", "package_ndc": "13107-104-01", "marketing_start_date": "20160426"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13107-104-30)", "package_ndc": "13107-104-30", "marketing_start_date": "20160426"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13107-104-99)", "package_ndc": "13107-104-99", "marketing_start_date": "20160426"}], "brand_name": "Oxymorphone Hydrochloride", "product_id": "13107-104_6c5c7596-0b2c-435f-a619-706b4424370d", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "13107-104", "dea_schedule": "CII", "generic_name": "Oxymorphone Hydrochloride", "labeler_name": "Aurolife Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxymorphone Hydrochloride", "active_ingredients": [{"name": "OXYMORPHONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA204459", "marketing_category": "ANDA", "marketing_start_date": "20160426", "listing_expiration_date": "20261231"}