oxaliplatin

Generic: oxaliplatin

Labeler: winthrop u.s, a business of sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler winthrop u.s, a business of sanofi-aventis u.s. llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
Winthrop U.S, a business of sanofi-aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0955-1733
Product ID 0955-1733_0bef8406-8dab-0ad0-e063-6394a90a60d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021759
Listing Expiration 2026-12-31
Marketing Start 2015-09-01

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09551733
Hyphenated Format 0955-1733

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 NDA021759 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0955-1733-20) / 20 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0955-1733-20 1 VIAL, GLASS in 1 CARTON (0955-1733-20) / 20 mL in 1 VIAL, GLASS

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": "0bef8406-8dab-0ad0-e063-6394a90a60d0", "openfda": {"nui": ["N0000175413", "N0000175073"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["70269278-fe61-4800-a064-32cb6845cc28"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Winthrop U.S, a business of sanofi-aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0955-1733-20)  / 20 mL in 1 VIAL, GLASS", "package_ndc": "0955-1733-20", "marketing_start_date": "20150901"}], "brand_name": "OXALIPLATIN", "product_id": "0955-1733_0bef8406-8dab-0ad0-e063-6394a90a60d0", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "0955-1733", "generic_name": "oxaliplatin", "labeler_name": "Winthrop U.S, a business of sanofi-aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXALIPLATIN", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "NDA021759", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20150901", "listing_expiration_date": "20261231"}