oxaliplatin

Generic: oxaliplatin

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler apotex corp.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6287
Product ID 60505-6287_e56ed9d9-cd5b-4ba2-82a3-eb805fbc1a5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204368
Listing Expiration 2026-12-31
Marketing Start 2024-04-23

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056287
Hyphenated Format 60505-6287

Supplemental Identifiers

RxCUI
1736776 1736781
UNII
04ZR38536J
NUI
N0000175413 N0000175073

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 oxaliplatin (source: ndc)
Generic Name oxaliplatin (source: ndc)
Application Number ANDA204368 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (60505-6287-2) / 10 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (60505-6287-4) / 20 mL in 1 VIAL
source: ndc

Packages (2)

60505-6287-2 1 VIAL in 1 CARTON (60505-6287-2) / 10 mL in 1 VIAL 60505-6287-4 1 VIAL in 1 CARTON (60505-6287-4) / 20 mL in 1 VIAL

Ingredients (1)

oxaliplatin (5 mg/mL)

Linked Drug Pages (1)

Oxaliplatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e56ed9d9-cd5b-4ba2-82a3-eb805fbc1a5b", "openfda": {"nui": ["N0000175413", "N0000175073"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["bb180ec5-1f75-43c1-9f63-c0657af2ca5f"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (60505-6287-2)  / 10 mL in 1 VIAL", "package_ndc": "60505-6287-2", "marketing_start_date": "20240423"}, {"sample": false, "description": "1 VIAL in 1 CARTON (60505-6287-4)  / 20 mL in 1 VIAL", "package_ndc": "60505-6287-4", "marketing_start_date": "20240423"}], "brand_name": "Oxaliplatin", "product_id": "60505-6287_e56ed9d9-cd5b-4ba2-82a3-eb805fbc1a5b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "60505-6287", "generic_name": "oxaliplatin", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "ANDA204368", "marketing_category": "ANDA", "marketing_start_date": "20240423", "listing_expiration_date": "20261231"}