oxycodone hydrochloride

Generic: oxycodone

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

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride
Generic Name oxycodone
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 10 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-048
Product ID 65162-048_8b9e3253-7735-44cc-a59b-3125ab573c84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203638
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2012-10-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162048
Hyphenated Format 65162-048

Supplemental Identifiers

RxCUI
1049611 1049618 1049621 1049683 1049686
UPC
0365162049107 0365162048100 0365162047103 0365162051032 0365162050035 0365162048032 0365162049039 0365162050103 0365162051100 0365162047035
UNII
C1ENJ2TE6C

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 oxycodone hydrochloride (source: ndc)
Generic Name oxycodone (source: ndc)
Application Number ANDA203638 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-048-03)
  • 100 TABLET in 1 BOTTLE (65162-048-10)
  • 250 TABLET in 1 BOTTLE (65162-048-25)
source: ndc

Packages (3)

65162-048-03 30 TABLET in 1 BOTTLE (65162-048-03) 65162-048-10 100 TABLET in 1 BOTTLE (65162-048-10) 65162-048-25 250 TABLET in 1 BOTTLE (65162-048-25)

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": "8b9e3253-7735-44cc-a59b-3125ab573c84", "openfda": {"upc": ["0365162049107", "0365162048100", "0365162047103", "0365162051032", "0365162050035", "0365162048032", "0365162049039", "0365162050103", "0365162051100", "0365162047035"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049611", "1049618", "1049621", "1049683", "1049686"], "spl_set_id": ["094b64b3-cd32-4de5-afb6-ea00d9caad74"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-048-03)", "package_ndc": "65162-048-03", "marketing_start_date": "20121030"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (65162-048-10)", "package_ndc": "65162-048-10", "marketing_start_date": "20121030"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (65162-048-25)", "package_ndc": "65162-048-25", "marketing_start_date": "20121030"}], "brand_name": "Oxycodone Hydrochloride", "product_id": "65162-048_8b9e3253-7735-44cc-a59b-3125ab573c84", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "65162-048", "dea_schedule": "CII", "generic_name": "Oxycodone", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone Hydrochloride", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA203638", "marketing_category": "ANDA", "marketing_start_date": "20121030", "listing_expiration_date": "20261231"}