oxaliplatin

Generic: oxaliplatin

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-314
Product ID 68083-314_4ccc9b7c-9bf8-4e27-8c38-f98e80360fcf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207325
Listing Expiration 2026-12-31
Marketing Start 2017-11-06

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083314
Hyphenated Format 68083-314

Supplemental Identifiers

RxCUI
1736776 1736781 1797528
UPC
0368083314019 0368083176013 0368083177010
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 ANDA207325 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (68083-314-01) / 40 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

68083-314-01 1 VIAL, SINGLE-USE in 1 CARTON (68083-314-01) / 40 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": "4ccc9b7c-9bf8-4e27-8c38-f98e80360fcf", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0368083314019", "0368083176013", "0368083177010"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781", "1797528"], "spl_set_id": ["a6f89dc3-a594-4b5b-8728-272e20c1ecb5"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (68083-314-01)  / 40 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68083-314-01", "marketing_start_date": "20171106"}], "brand_name": "Oxaliplatin", "product_id": "68083-314_4ccc9b7c-9bf8-4e27-8c38-f98e80360fcf", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "68083-314", "generic_name": "Oxaliplatin", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "ANDA207325", "marketing_category": "ANDA", "marketing_start_date": "20171106", "listing_expiration_date": "20261231"}