cisplatin

Generic: cisplatin

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cisplatin
Generic Name cisplatin
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cisplatin 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-103
Product ID 63323-103_24604fc6-875c-4f70-973a-9cca93f9a7a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074735
Listing Expiration 2026-12-31
Marketing Start 2000-09-05

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323103
Hyphenated Format 63323-103

Supplemental Identifiers

RxCUI
309311
UNII
Q20Q21Q62J
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 cisplatin (source: ndc)
Generic Name cisplatin (source: ndc)
Application Number ANDA074735 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (63323-103-51) / 50 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (63323-103-64) / 200 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (63323-103-65) / 100 mL in 1 VIAL
source: ndc

Packages (3)

63323-103-51 1 VIAL in 1 CARTON (63323-103-51) / 50 mL in 1 VIAL 63323-103-64 1 VIAL in 1 CARTON (63323-103-64) / 200 mL in 1 VIAL 63323-103-65 1 VIAL in 1 CARTON (63323-103-65) / 100 mL in 1 VIAL

Ingredients (1)

cisplatin (1 mg/mL)

Linked Drug Pages (1)

Cisplatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "24604fc6-875c-4f70-973a-9cca93f9a7a7", "openfda": {"nui": ["N0000175413", "N0000175073"], "unii": ["Q20Q21Q62J"], "rxcui": ["309311"], "spl_set_id": ["de6302d5-85f0-4116-a709-57826c2c84fe"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (63323-103-51)  / 50 mL in 1 VIAL", "package_ndc": "63323-103-51", "marketing_start_date": "20000905"}, {"sample": false, "description": "1 VIAL in 1 CARTON (63323-103-64)  / 200 mL in 1 VIAL", "package_ndc": "63323-103-64", "marketing_start_date": "20000905"}, {"sample": false, "description": "1 VIAL in 1 CARTON (63323-103-65)  / 100 mL in 1 VIAL", "package_ndc": "63323-103-65", "marketing_start_date": "20000905"}], "brand_name": "Cisplatin", "product_id": "63323-103_24604fc6-875c-4f70-973a-9cca93f9a7a7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "63323-103", "generic_name": "CISPLATIN", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cisplatin", "active_ingredients": [{"name": "CISPLATIN", "strength": "1 mg/mL"}], "application_number": "ANDA074735", "marketing_category": "ANDA", "marketing_start_date": "20000905", "listing_expiration_date": "20261231"}