oxycodone hydrochloride

Generic: oxycodone hydrochloride

Labeler: genus lifesciences inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride
Generic Name oxycodone hydrochloride
Labeler genus lifesciences inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 5 mg/5mL

Manufacturer
Genus Lifesciences Inc.

Identifiers & Regulatory

Product NDC 64950-354
Product ID 64950-354_f06a167a-fef6-4f5e-b7e2-aeb340ddb9d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200535
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2013-09-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64950354
Hyphenated Format 64950-354

Supplemental Identifiers

RxCUI
1049604 1049615
UPC
0364950353037 0364950354058
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 hydrochloride (source: ndc)
Application Number NDA200535 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (64950-354-10) / 100 mL in 1 BOTTLE, PLASTIC
  • 40 CUP, UNIT-DOSE in 1 CASE (64950-354-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)
  • 1 BOTTLE, PLASTIC in 1 CARTON (64950-354-50) / 500 mL in 1 BOTTLE, PLASTIC
  • 50 CUP, UNIT-DOSE in 1 CASE (64950-354-55) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)
source: ndc

Packages (4)

Ingredients (1)

oxycodone hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "f06a167a-fef6-4f5e-b7e2-aeb340ddb9d7", "openfda": {"upc": ["0364950353037", "0364950354058"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049604", "1049615"], "spl_set_id": ["6869fec9-1837-4221-afd8-5cc6fadd025d"], "manufacturer_name": ["Genus Lifesciences Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (64950-354-10)  / 100 mL in 1 BOTTLE, PLASTIC", "package_ndc": "64950-354-10", "marketing_start_date": "20130909"}, {"sample": false, "description": "40 CUP, UNIT-DOSE in 1 CASE (64950-354-45)  / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)", "package_ndc": "64950-354-45", "marketing_start_date": "20130909"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (64950-354-50)  / 500 mL in 1 BOTTLE, PLASTIC", "package_ndc": "64950-354-50", "marketing_start_date": "20130909"}, {"sample": false, "description": "50 CUP, UNIT-DOSE in 1 CASE (64950-354-55)  / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)", "package_ndc": "64950-354-55", "marketing_start_date": "20130909"}], "brand_name": "Oxycodone Hydrochloride", "product_id": "64950-354_f06a167a-fef6-4f5e-b7e2-aeb340ddb9d7", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "64950-354", "dea_schedule": "CII", "generic_name": "Oxycodone Hydrochloride", "labeler_name": "Genus Lifesciences Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone Hydrochloride", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "NDA200535", "marketing_category": "NDA", "marketing_start_date": "20130909", "listing_expiration_date": "20261231"}