oxycodone hydrochloride

Generic: oxycodone hydrochloride

Labeler: hikma pharmceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride
Generic Name oxycodone hydrochloride
Labeler hikma pharmceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 5 mg/5mL

Manufacturer
Hikma Pharmceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0390
Product ID 0054-0390_47e856d4-de7d-49aa-8671-d1b4a35bad4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204037
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2014-09-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540390
Hyphenated Format 0054-0390

Supplemental Identifiers

RxCUI
1049604
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 ANDA204037 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (0054-0390-41)
  • 500 mL in 1 BOTTLE (0054-0390-63)
source: ndc

Packages (2)

0054-0390-41 15 mL in 1 BOTTLE (0054-0390-41) 0054-0390-63 500 mL in 1 BOTTLE (0054-0390-63)

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": "47e856d4-de7d-49aa-8671-d1b4a35bad4d", "openfda": {"unii": ["C1ENJ2TE6C"], "rxcui": ["1049604"], "spl_set_id": ["d8e87c66-f872-4e1d-9ade-ef11490af63b"], "manufacturer_name": ["Hikma Pharmceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (0054-0390-41)", "package_ndc": "0054-0390-41", "marketing_end_date": "20260831", "marketing_start_date": "20140904"}, {"sample": false, "description": "500 mL in 1 BOTTLE (0054-0390-63)", "package_ndc": "0054-0390-63", "marketing_start_date": "20140904"}], "brand_name": "oxycodone hydrochloride", "product_id": "0054-0390_47e856d4-de7d-49aa-8671-d1b4a35bad4d", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-0390", "dea_schedule": "CII", "generic_name": "oxycodone hydrochloride", "labeler_name": "Hikma Pharmceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxycodone hydrochloride", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA204037", "marketing_category": "ANDA", "marketing_start_date": "20140904", "listing_expiration_date": "20271231"}