oxaliplatin

Generic: oxaliplatin

Labeler: teva parenteral medicines, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

oxaliplatin 50 mg/10mL

Manufacturer
Teva Parenteral Medicines, Inc.

Identifiers & Regulatory

Product NDC 0703-3985
Product ID 0703-3985_b349bdd1-79de-44e6-ab0b-892a65bda6f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022160
Marketing Start 2009-08-11
Marketing End 2026-03-31

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07033985
Hyphenated Format 0703-3985

Supplemental Identifiers

RxCUI
1736776 1736781
UPC
0307033986012 0307033985015
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 NDA022160 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0703-3985-01) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0703-3985-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-3985-01) / 10 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

oxaliplatin (50 mg/10mL)

Linked Drug Pages (1)

Oxaliplatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b349bdd1-79de-44e6-ab0b-892a65bda6f6", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0307033986012", "0307033985015"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["9e51cc79-620c-48d7-b267-78e43c1ef6e4"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Teva Parenteral Medicines, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0703-3985-01)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0703-3985-01", "marketing_end_date": "20260331", "marketing_start_date": "20090811"}], "brand_name": "Oxaliplatin", "product_id": "0703-3985_b349bdd1-79de-44e6-ab0b-892a65bda6f6", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "0703-3985", "generic_name": "Oxaliplatin", "labeler_name": "Teva Parenteral Medicines, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "50 mg/10mL"}], "application_number": "NDA022160", "marketing_category": "NDA", "marketing_end_date": "20260331", "marketing_start_date": "20090811"}