oxaliplatin

Generic: oxaliplatin

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler accord healthcare inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-332
Product ID 16729-332_0e2ec613-5375-858e-e063-6294a90ab95a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207474
Listing Expiration 2026-12-31
Marketing Start 2018-05-17

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729332
Hyphenated Format 16729-332

Supplemental Identifiers

RxCUI
1736776 1736781 1797528
UPC
0316729332354 0316729332057 0316729332033
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 ANDA207474 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-03) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-05) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

16729-332-03 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-03) / 10 mL in 1 VIAL, SINGLE-DOSE 16729-332-05 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-05) / 20 mL in 1 VIAL, SINGLE-DOSE

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": "0e2ec613-5375-858e-e063-6294a90ab95a", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0316729332354", "0316729332057", "0316729332033"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781", "1797528"], "spl_set_id": ["4b805925-beb1-2bac-e054-00144ff88e88"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-03)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "16729-332-03", "marketing_start_date": "20180517"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-05)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "16729-332-05", "marketing_start_date": "20180517"}], "brand_name": "oxaliplatin", "product_id": "16729-332_0e2ec613-5375-858e-e063-6294a90ab95a", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "16729-332", "generic_name": "oxaliplatin", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "ANDA207474", "marketing_category": "ANDA", "marketing_start_date": "20180517", "listing_expiration_date": "20261231"}