oxaliplatin

Generic: oxaliplatin

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-750
Product ID 63323-750_504bf43e-4c28-4375-a6f4-285b2357f7f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078811
Listing Expiration 2026-12-31
Marketing Start 2010-06-11

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323750
Hyphenated Format 63323-750

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 ANDA078811 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Oxaliplatin Injection, USP is supplied in clear, glass, single-dose vials containing 50 mg or 100 mg of oxaliplatin as a clear, colorless, sterile, preservative-free, aqueous solution at a concentration of 5 mg per mL. Water for Injection USP is present as an inactive ingredient. Product Code Unit of Sale Strength Each 775010 NDC 63323-750-10 Individually packaged 50 mg per 10 mL (5 mg per mL) 10 mL Single Dose Vial 775020 NDC 63323-750-20 Individually packaged 100 mg per 20 mL (5 mg per mL) 20 mL Single Dose Vial The container closure is not made with natural rubber latex. Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze and protect from light (keep in original outer carton). Oxaliplatin is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 The use of gloves is recommended. If a solution of Oxaliplatin contacts the skin, wash the skin immediately and thoroughly with soap and water. If Oxaliplatin contacts the mucous membranes, flush thoroughly with water.
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL- 50 mg per 10 mL- Vial Label NDC 63323-750-10 775010 Oxaliplatin Injection, USP 50 mg per 10 mL (5 mg per mL) For intravenous use only. MUST BE DILUTED WITH 5% DEXTROSE INJECTION BEFORE USE. Preservative free. Cytotoxic agent. Do not mix or add to sodium chloride/chloride-containing solutions. Rx only Single Dose Vial PACKAGE LABEL PRINCIPAL DISPLAY PANEL- 50 mg per 10 mL- Vial Label
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL- 50 mg per 10 mL- Vial Carton Panel NDC 63323-750-10 775010 Oxaliplatin Injection, USP 50 mg per 10 mL (5 mg per mL) For intravenous use only. MUST BE DILUTED WITH 5% DEXTROSE INJECTION BEFORE USE. Preservative free. Cytotoxic agent. Do not mix or add to sodium chloride/chloride-containing solutions. Single Dose Vial Rx only PACKAGE LABEL PRINCIPAL DISPLAY PANEL- 50 mg per 10 mL- Vial Carton Panel
source: label

Packages (0)

No package records.

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": "504bf43e-4c28-4375-a6f4-285b2357f7f7", "openfda": {"nui": ["N0000175413", "N0000175073"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["e12e2850-4980-48de-af58-15e559fb921f"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Oxaliplatin", "product_id": "63323-750_504bf43e-4c28-4375-a6f4-285b2357f7f7", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "63323-750", "generic_name": "Oxaliplatin", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "ANDA078811", "marketing_category": "ANDA", "marketing_start_date": "20100611", "listing_expiration_date": "20261231"}