OXYCODONE HYDROCHLORIDE

Generic: OXYCODONE HYDROCHLORIDE

Labeler: PAI Holdings, LLC dba PAI Pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name OXYCODONE HYDROCHLORIDE
Generic Name OXYCODONE HYDROCHLORIDE
Labeler PAI Holdings, LLC dba PAI Pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

OXYCODONE HYDROCHLORIDE 100 mg/5mL

Identifiers & Regulatory

Product NDC 0121-0826
Product ID 0121-0826_1109a611-cf88-4447-b2ac-de7fc081a094
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206822
DEA Schedule CII
Listing Expiration 2026-12-31
Marketing Start 2018-06-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210826
Hyphenated Format 0121-0826

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 ANDA206822 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0121-0826-01) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

0121-0826-01 1 BOTTLE in 1 CARTON (0121-0826-01) / 30 mL in 1 BOTTLE

Ingredients (1)

OXYCODONE HYDROCHLORIDE (100 mg/5mL)

Linked Drug Pages (1)

OXYCODONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1109a611-cf88-4447-b2ac-de7fc081a094", "openfda": {"unii": ["C1ENJ2TE6C"], "rxcui": ["1049615"], "spl_set_id": ["54ece3f4-6ba1-411e-a0c6-2141a400b71a"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0121-0826-01)  / 30 mL in 1 BOTTLE", "package_ndc": "0121-0826-01", "marketing_start_date": "20180604"}], "brand_name": "OXYCODONE HYDROCHLORIDE", "product_id": "0121-0826_1109a611-cf88-4447-b2ac-de7fc081a094", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0121-0826", "dea_schedule": "CII", "generic_name": "OXYCODONE HYDROCHLORIDE", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXYCODONE HYDROCHLORIDE", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "100 mg/5mL"}], "application_number": "ANDA206822", "marketing_category": "ANDA", "marketing_start_date": "20180604", "listing_expiration_date": "20261231"}