oxycodone hydrochloride

Generic: oxycodone hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 5 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0827
Product ID 0121-0827_1685138a-dd0b-4e6e-b14d-a1132eef8b34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206914
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2019-04-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210827
Hyphenated Format 0121-0827

Supplemental Identifiers

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 ANDA206914 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (0121-0827-04)
  • 500 mL in 1 BOTTLE (0121-0827-16)
source: ndc

Packages (2)

0121-0827-04 118 mL in 1 BOTTLE (0121-0827-04) 0121-0827-16 500 mL in 1 BOTTLE (0121-0827-16)

Ingredients (1)

oxycodone hydrochloride (5 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": "1685138a-dd0b-4e6e-b14d-a1132eef8b34", "openfda": {"unii": ["C1ENJ2TE6C"], "spl_set_id": ["73b063b5-24b7-40bf-bc2a-c0e1bfaf61d1"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (0121-0827-04)", "package_ndc": "0121-0827-04", "marketing_start_date": "20190408"}, {"sample": false, "description": "500 mL in 1 BOTTLE (0121-0827-16)", "package_ndc": "0121-0827-16", "marketing_start_date": "20190408"}], "brand_name": "OXYCODONE HYDROCHLORIDE", "product_id": "0121-0827_1685138a-dd0b-4e6e-b14d-a1132eef8b34", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0121-0827", "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": "5 mg/5mL"}], "application_number": "ANDA206914", "marketing_category": "ANDA", "marketing_start_date": "20190408", "listing_expiration_date": "20271231"}