oxaliplatin

Generic: oxaliplatin

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-149
Product ID 71288-149_fb8d544c-a5df-4648-9422-9d53141d3a70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207325
Marketing Start 2017-10-01
Marketing End 2027-02-28

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288149
Hyphenated Format 71288-149

Supplemental Identifiers

RxCUI
1736776 1736781
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-DOSE in 1 CARTON (71288-149-95) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-149-96) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

71288-149-95 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-149-95) / 10 mL in 1 VIAL, SINGLE-DOSE 71288-149-96 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-149-96) / 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": "fb8d544c-a5df-4648-9422-9d53141d3a70", "openfda": {"nui": ["N0000175413", "N0000175073"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["7e38318e-c569-4ad4-8f10-a235f30444d1"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-149-95)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-149-95", "marketing_end_date": "20270228", "marketing_start_date": "20171001"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-149-96)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-149-96", "marketing_end_date": "20270228", "marketing_start_date": "20171001"}], "brand_name": "Oxaliplatin", "product_id": "71288-149_fb8d544c-a5df-4648-9422-9d53141d3a70", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "71288-149", "generic_name": "Oxaliplatin", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxaliplatin", "active_ingredients": [{"name": "OXALIPLATIN", "strength": "5 mg/mL"}], "application_number": "ANDA207325", "marketing_category": "ANDA", "marketing_end_date": "20270228", "marketing_start_date": "20171001"}