oxaliplatin

Generic: oxaliplatin

Labeler: qilu pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler qilu pharmaceutical co., ltd.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 50 mg/10mL

Manufacturer
Qilu Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 67184-0501
Product ID 67184-0501_f9f54aa0-22e3-4958-b368-d89d716ac2fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204616
Listing Expiration 2026-12-31
Marketing Start 2016-05-11

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 671840501
Hyphenated Format 67184-0501

Supplemental Identifiers

RxCUI
1736784 1736786
UPC
0367184050116 0367184050215
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 ANDA204616 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (67184-0501-1) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

67184-0501-1 1 VIAL, SINGLE-DOSE in 1 CARTON (67184-0501-1) / 10 mL in 1 VIAL, SINGLE-DOSE

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": "f9f54aa0-22e3-4958-b368-d89d716ac2fa", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0367184050116", "0367184050215"], "unii": ["04ZR38536J"], "rxcui": ["1736784", "1736786"], "spl_set_id": ["e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Qilu Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (67184-0501-1)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67184-0501-1", "marketing_start_date": "20160511"}], "brand_name": "Oxaliplatin", "product_id": "67184-0501_f9f54aa0-22e3-4958-b368-d89d716ac2fa", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "67184-0501", "generic_name": "Oxaliplatin", "labeler_name": "Qilu Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "50 mg/10mL"}], "application_number": "ANDA204616", "marketing_category": "ANDA", "marketing_start_date": "20160511", "listing_expiration_date": "20261231"}