oxycodone hydrochloride (76420-764)

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 15 mg/1

Manufacturer

Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-764

Product ID 76420-764_1bb160c8-a76d-7033-e063-6294a90adbef

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202116

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2011-12-30

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420764

Hyphenated Format 76420-764

Supplemental Identifiers

RxCUI

1049611 1049618 1049621

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 ANDA202116 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

15 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (76420-764-01)
500 TABLET in 1 BOTTLE (76420-764-05)
10 TABLET in 1 BOTTLE (76420-764-10)
20 TABLET in 1 BOTTLE (76420-764-20)
30 TABLET in 1 BOTTLE (76420-764-30)
60 TABLET in 1 BOTTLE (76420-764-60)
90 TABLET in 1 BOTTLE (76420-764-90)

source: ndc

Packages (7)

76420-764-01 100 TABLET in 1 BOTTLE (76420-764-01) 76420-764-05 500 TABLET in 1 BOTTLE (76420-764-05) 76420-764-10 10 TABLET in 1 BOTTLE (76420-764-10) 76420-764-20 20 TABLET in 1 BOTTLE (76420-764-20) 76420-764-30 30 TABLET in 1 BOTTLE (76420-764-30) 76420-764-60 60 TABLET in 1 BOTTLE (76420-764-60) 76420-764-90 90 TABLET in 1 BOTTLE (76420-764-90)

Ingredients (1)

oxycodone hydrochloride (15 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": "1bb160c8-a76d-7033-e063-6294a90adbef", "openfda": {"unii": ["C1ENJ2TE6C"], "rxcui": ["1049611", "1049618", "1049621"], "spl_set_id": ["1bb147d4-1ab6-dd70-e063-6394a90a67a8"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-764-01)", "package_ndc": "76420-764-01", "marketing_start_date": "20240625"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76420-764-05)", "package_ndc": "76420-764-05", "marketing_start_date": "20240625"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (76420-764-10)", "package_ndc": "76420-764-10", "marketing_start_date": "20240625"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (76420-764-20)", "package_ndc": "76420-764-20", "marketing_start_date": "20240625"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-764-30)", "package_ndc": "76420-764-30", "marketing_start_date": "20240625"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-764-60)", "package_ndc": "76420-764-60", "marketing_start_date": "20240625"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-764-90)", "package_ndc": "76420-764-90", "marketing_start_date": "20240625"}], "brand_name": "Oxycodone hydrochloride", "product_id": "76420-764_1bb160c8-a76d-7033-e063-6294a90adbef", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76420-764", "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": "15 mg/1"}], "application_number": "ANDA202116", "marketing_category": "ANDA", "marketing_start_date": "20111230", "listing_expiration_date": "20261231"}