oxycodone hydrochloride

Generic: oxycodone hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride
Generic Name oxycodone hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 10 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-363
Product ID 76420-363_46f094b6-4d19-8b98-e063-6294a90a5aac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077712
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-09-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420363
Hyphenated Format 76420-363

Supplemental Identifiers

RxCUI
1049611 1049618 1049621 1049683 1049686
UNII
C1ENJ2TE6C

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 oxycodone hydrochloride (source: ndc)
Generic Name oxycodone hydrochloride (source: ndc)
Application Number ANDA077712 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (76420-363-01)
  • 10 TABLET in 1 BOTTLE, PLASTIC (76420-363-10)
  • 30 TABLET in 1 BOTTLE, PLASTIC (76420-363-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (76420-363-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (76420-363-90)
source: ndc

Packages (5)

76420-363-01 100 TABLET in 1 BOTTLE, PLASTIC (76420-363-01) 76420-363-10 10 TABLET in 1 BOTTLE, PLASTIC (76420-363-10) 76420-363-30 30 TABLET in 1 BOTTLE, PLASTIC (76420-363-30) 76420-363-60 60 TABLET in 1 BOTTLE, PLASTIC (76420-363-60) 76420-363-90 90 TABLET in 1 BOTTLE, PLASTIC (76420-363-90)

Ingredients (1)

oxycodone hydrochloride (10 mg/1)

Linked Drug Pages (1)

Oxycodone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46f094b6-4d19-8b98-e063-6294a90a5aac", "openfda": {"unii": ["C1ENJ2TE6C"], "rxcui": ["1049611", "1049618", "1049621", "1049683", "1049686"], "spl_set_id": ["056bdaac-4a43-42f0-9435-f349d3ccc128"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (76420-363-01)", "package_ndc": "76420-363-01", "marketing_start_date": "20250527"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (76420-363-10)", "package_ndc": "76420-363-10", "marketing_start_date": "20251227"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (76420-363-30)", "package_ndc": "76420-363-30", "marketing_start_date": "20250527"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (76420-363-60)", "package_ndc": "76420-363-60", "marketing_start_date": "20250527"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (76420-363-90)", "package_ndc": "76420-363-90", "marketing_start_date": "20250527"}], "brand_name": "Oxycodone Hydrochloride", "product_id": "76420-363_46f094b6-4d19-8b98-e063-6294a90a5aac", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76420-363", "dea_schedule": "CII", "generic_name": "Oxycodone Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone Hydrochloride", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077712", "marketing_category": "ANDA", "marketing_start_date": "20240910", "listing_expiration_date": "20261231"}