oxaliplatin

Generic: oxaliplatin

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler sandoz inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-9317
Product ID 0781-9317_ac83b4cd-5026-4dd5-b733-125d28ba3c95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078817
Listing Expiration 2026-12-31
Marketing Start 2016-07-01

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07819317
Hyphenated Format 0781-9317

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 ANDA078817 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0781-9317-80) / 20 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0781-9317-80 1 VIAL, SINGLE-USE in 1 CARTON (0781-9317-80) / 20 mL in 1 VIAL, SINGLE-USE

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": "ac83b4cd-5026-4dd5-b733-125d28ba3c95", "openfda": {"nui": ["N0000175413", "N0000175073"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["86f6c19d-30d1-42e3-8d46-5e3f45776e85"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0781-9317-80)  / 20 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0781-9317-80", "marketing_start_date": "20160701"}], "brand_name": "Oxaliplatin", "product_id": "0781-9317_ac83b4cd-5026-4dd5-b733-125d28ba3c95", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "0781-9317", "generic_name": "Oxaliplatin", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "ANDA078817", "marketing_category": "ANDA", "marketing_start_date": "20160701", "listing_expiration_date": "20261231"}