oxycodone hydrochloride
Generic: oxycodone hydrochloride
Labeler: genus lifesciences inc.Drug Facts
Product Profile
Brand Name
oxycodone hydrochloride
Generic Name
oxycodone hydrochloride
Labeler
genus lifesciences inc.
Dosage Form
SOLUTION
Routes
Active Ingredients
oxycodone hydrochloride 5 mg/5mL
Manufacturer
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
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
64950354
Hyphenated Format
64950-354
Supplemental Identifiers
RxCUI
UPC
UNII
Packaging Origin
Original Packager
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
source: ndc
Resolved Composition
Strengths
- 5 mg/5mL
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)
Packages (4)
64950-354-10
1 BOTTLE, PLASTIC in 1 CARTON (64950-354-10) / 100 mL in 1 BOTTLE, PLASTIC
64950-354-45
40 CUP, UNIT-DOSE in 1 CASE (64950-354-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)
64950-354-50
1 BOTTLE, PLASTIC in 1 CARTON (64950-354-50) / 500 mL in 1 BOTTLE, PLASTIC
64950-354-55
50 CUP, UNIT-DOSE in 1 CASE (64950-354-55) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)
Ingredients (1)
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"}