oxaliplatin

Generic: oxaliplatin

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-442
Product ID 67457-442_01a705c0-0014-4a63-aa66-918cdcc2df67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091358
Listing Expiration 2026-12-31
Marketing Start 2014-05-16

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457442
Hyphenated Format 67457-442

Supplemental Identifiers

RxCUI
1736776 1736781
UPC
0367457469102 0367457442204
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 ANDA091358 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (67457-442-20) / 20 mL in 1 VIAL
source: ndc

Packages (1)

67457-442-20 1 VIAL in 1 CARTON (67457-442-20) / 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": "01a705c0-0014-4a63-aa66-918cdcc2df67", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0367457469102", "0367457442204"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["da0e8523-609a-4326-96b1-d7de78662d91"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (67457-442-20)  / 20 mL in 1 VIAL", "package_ndc": "67457-442-20", "marketing_start_date": "20140516"}], "brand_name": "Oxaliplatin", "product_id": "67457-442_01a705c0-0014-4a63-aa66-918cdcc2df67", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "67457-442", "generic_name": "Oxaliplatin", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "ANDA091358", "marketing_category": "ANDA", "marketing_start_date": "20140516", "listing_expiration_date": "20261231"}