oxycodone hydrochloride

Generic: oxycodone hydrochloride

Labeler: ascent pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride
Generic Name oxycodone hydrochloride
Labeler ascent pharmaceuticals inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 100 mg/5mL

Manufacturer
Ascent Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 43602-198
Product ID 43602-198_46183e47-ba04-4b02-912a-6aeed41c609e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209021
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-07-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43602198
Hyphenated Format 43602-198

Supplemental Identifiers

RxCUI
1049604 1049615
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 ANDA209021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE (43602-198-31)
  • 500 mL in 1 BOTTLE (43602-198-50)
source: ndc

Packages (2)

43602-198-31 30 mL in 1 BOTTLE (43602-198-31) 43602-198-50 500 mL in 1 BOTTLE (43602-198-50)

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": "46183e47-ba04-4b02-912a-6aeed41c609e", "openfda": {"unii": ["C1ENJ2TE6C"], "rxcui": ["1049604", "1049615"], "spl_set_id": ["de96e2be-66d9-4bcb-a133-221ad32e09f1"], "manufacturer_name": ["Ascent Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (43602-198-31)", "package_ndc": "43602-198-31", "marketing_start_date": "20170713"}, {"sample": false, "description": "500 mL in 1 BOTTLE (43602-198-50)", "package_ndc": "43602-198-50", "marketing_start_date": "20170713"}], "brand_name": "OXYCODONE HYDROCHLORIDE", "product_id": "43602-198_46183e47-ba04-4b02-912a-6aeed41c609e", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "43602-198", "dea_schedule": "CII", "generic_name": "OXYCODONE HYDROCHLORIDE", "labeler_name": "Ascent Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXYCODONE HYDROCHLORIDE", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "100 mg/5mL"}], "application_number": "ANDA209021", "marketing_category": "ANDA", "marketing_start_date": "20170713", "listing_expiration_date": "20261231"}