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, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 50 mg/10mL

Manufacturer
Qilu Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 67184-0508
Product ID 67184-0508_e78605b3-b28b-4634-9a58-d4bda67832ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204368
Listing Expiration 2026-12-31
Marketing Start 2016-06-07

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 671840508
Hyphenated Format 67184-0508

Supplemental Identifiers

RxCUI
1736776 1736781 1797528
UPC
0367184050918 0367184051014 0367184050819
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 ANDA204368 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (67184-0508-1) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

67184-0508-1 1 VIAL, SINGLE-USE in 1 CARTON (67184-0508-1) / 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": "e78605b3-b28b-4634-9a58-d4bda67832ba", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0367184050918", "0367184051014", "0367184050819"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781", "1797528"], "spl_set_id": ["33d4f4b4-bb4e-46af-9e89-df20154436d0"], "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-USE in 1 CARTON (67184-0508-1)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "67184-0508-1", "marketing_start_date": "20160607"}], "brand_name": "Oxaliplatin", "product_id": "67184-0508_e78605b3-b28b-4634-9a58-d4bda67832ba", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "67184-0508", "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": "ANDA204368", "marketing_category": "ANDA", "marketing_start_date": "20160607", "listing_expiration_date": "20261231"}