oxaliplatin

Generic: oxaliplatin

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 61703-363
Product ID 61703-363_ecdfccf3-58e8-47ce-89d3-53a4d3e3af21
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078813
Listing Expiration 2026-12-31
Marketing Start 2009-08-10

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61703363
Hyphenated Format 61703-363

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 ANDA078813 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-18) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-22) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

61703-363-18 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-18) / 10 mL in 1 VIAL, SINGLE-DOSE 61703-363-22 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-22) / 20 mL in 1 VIAL, SINGLE-DOSE

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": "ecdfccf3-58e8-47ce-89d3-53a4d3e3af21", "openfda": {"nui": ["N0000175413", "N0000175073"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["e51a62ba-d163-4c57-835c-8c86cf097e40"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-18)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "61703-363-18", "marketing_start_date": "20090810"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-22)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "61703-363-22", "marketing_start_date": "20090810"}], "brand_name": "Oxaliplatin", "product_id": "61703-363_ecdfccf3-58e8-47ce-89d3-53a4d3e3af21", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "61703-363", "generic_name": "OXALIPLATIN", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "ANDA078813", "marketing_category": "ANDA", "marketing_start_date": "20090810", "listing_expiration_date": "20261231"}