oxymorphone hydrochloride

Generic: oxymorphone hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxymorphone hydrochloride
Generic Name oxymorphone hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxymorphone hydrochloride 7.5 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1315
Product ID 0115-1315_a8dc6624-df1e-4e5a-b445-9541658e3430
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079087
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2013-01-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151315
Hyphenated Format 0115-1315

Supplemental Identifiers

RxCUI
977874 977894 977902 977909 977915 977923 977929
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 ANDA079087 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-01)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-03)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-08)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-13)
source: ndc

Packages (4)

0115-1315-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-01) 0115-1315-03 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-03) 0115-1315-08 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-08) 0115-1315-13 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-13)

Ingredients (1)

oxymorphone hydrochloride (7.5 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": "a8dc6624-df1e-4e5a-b445-9541658e3430", "openfda": {"unii": ["5Y2EI94NBC"], "rxcui": ["977874", "977894", "977902", "977909", "977915", "977923", "977929"], "spl_set_id": ["557e9610-62d7-42bf-90c1-44215bd8c1f8"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-01)", "package_ndc": "0115-1315-01", "marketing_start_date": "20130102"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-03)", "package_ndc": "0115-1315-03", "marketing_start_date": "20130102"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-08)", "package_ndc": "0115-1315-08", "marketing_start_date": "20130102"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-13)", "package_ndc": "0115-1315-13", "marketing_start_date": "20130102"}], "brand_name": "Oxymorphone hydrochloride", "product_id": "0115-1315_a8dc6624-df1e-4e5a-b445-9541658e3430", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0115-1315", "dea_schedule": "CII", "generic_name": "Oxymorphone hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxymorphone hydrochloride", "active_ingredients": [{"name": "OXYMORPHONE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA079087", "marketing_category": "ANDA", "marketing_start_date": "20130102", "listing_expiration_date": "20261231"}