oxaliplatin

Generic: oxaliplatin

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-332
Product ID 55150-332_faf81c5b-2d7e-4e6f-825b-f8a8399c0066
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205529
Listing Expiration 2026-12-31
Marketing Start 2017-09-21

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150332
Hyphenated Format 55150-332

Supplemental Identifiers

RxCUI
1736776 1736781
UPC
0355150332014 0355150331017
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 ANDA205529 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (55150-332-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

55150-332-01 1 VIAL in 1 CARTON (55150-332-01) / 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": "faf81c5b-2d7e-4e6f-825b-f8a8399c0066", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0355150332014", "0355150331017"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["1bb4febd-0ed4-48c9-ba2a-e22183a2143f"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (55150-332-01)  / 20 mL in 1 VIAL", "package_ndc": "55150-332-01", "marketing_start_date": "20170921"}], "brand_name": "Oxaliplatin", "product_id": "55150-332_faf81c5b-2d7e-4e6f-825b-f8a8399c0066", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "55150-332", "generic_name": "Oxaliplatin", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "ANDA205529", "marketing_category": "ANDA", "marketing_start_date": "20170921", "listing_expiration_date": "20261231"}