oxaliplatin

Generic: oxaliplatin

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxaliplatin 5 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-172
Product ID 71288-172_50b4c21f-714a-4a01-bf28-a856b19914d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217348
Listing Expiration 2026-12-31
Marketing Start 2024-01-11

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288172
Hyphenated Format 71288-172

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 ANDA217348 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-172-21) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-172-21 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-172-21) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

oxaliplatin (5 mg/mL)

Linked Drug Pages (2)

Oxaliplatin ndc-match (0.9) Oxaliplatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "50b4c21f-714a-4a01-bf28-a856b19914d1", "openfda": {"nui": ["N0000175413", "N0000175073"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["ee2e0da9-5ae7-405b-8dd1-635be72bc439"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-172-21)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-172-21", "marketing_start_date": "20240111"}], "brand_name": "Oxaliplatin", "product_id": "71288-172_50b4c21f-714a-4a01-bf28-a856b19914d1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "71288-172", "generic_name": "Oxaliplatin", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "ANDA217348", "marketing_category": "ANDA", "marketing_start_date": "20240111", "listing_expiration_date": "20261231"}