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, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 50 mg/10mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-170
Product ID 68083-170_0d039035-85d1-40d4-8ee6-540026ab7a5c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207385
Listing Expiration 2026-12-31
Marketing Start 2017-05-29

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083170
Hyphenated Format 68083-170

Supplemental Identifiers

RxCUI
1736784 1736786
UPC
0368083171018 0368083170011
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 ANDA207385 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 10 mL in 1 VIAL (68083-170-01)
source: ndc

Packages (1)

68083-170-01 10 mL in 1 VIAL (68083-170-01)

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": "0d039035-85d1-40d4-8ee6-540026ab7a5c", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0368083171018", "0368083170011"], "unii": ["04ZR38536J"], "rxcui": ["1736784", "1736786"], "spl_set_id": ["d6178bc6-9dae-413f-8f47-de75d576c5b8"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL (68083-170-01)", "package_ndc": "68083-170-01", "marketing_start_date": "20170529"}], "brand_name": "Oxaliplatin", "product_id": "68083-170_0d039035-85d1-40d4-8ee6-540026ab7a5c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "68083-170", "generic_name": "Oxaliplatin", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "50 mg/10mL"}], "application_number": "ANDA207385", "marketing_category": "ANDA", "marketing_start_date": "20170529", "listing_expiration_date": "20261231"}