oxaliplatin

Generic: oxaliplatin

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxaliplatin
Generic Name oxaliplatin
Labeler northstar rx llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oxaliplatin 5 mg/mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-101
Product ID 72603-101_f7b91231-4045-45a6-97c3-72fa9deaccf6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207325
Marketing Start 2019-06-17
Marketing End 2027-03-31

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603101
Hyphenated Format 72603-101

Supplemental Identifiers

RxCUI
1736776 1736781
UPC
0372603101010 0372603301014
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 (72603-101-01) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

72603-101-01 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-101-01) / 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": "f7b91231-4045-45a6-97c3-72fa9deaccf6", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0372603101010", "0372603301014"], "unii": ["04ZR38536J"], "rxcui": ["1736776", "1736781"], "spl_set_id": ["f299b2d2-86ed-4fb8-822e-65455a0bb75a"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (72603-101-01)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "72603-101-01", "marketing_end_date": "20270331", "marketing_start_date": "20190617"}], "brand_name": "Oxaliplatin", "product_id": "72603-101_f7b91231-4045-45a6-97c3-72fa9deaccf6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "72603-101", "generic_name": "Oxaliplatin", "labeler_name": "NorthStar Rx LLC", "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": "20270331", "marketing_start_date": "20190617"}