cisplatin

Generic: cisplatin

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

Drug Facts

Product Profile

Brand Name cisplatin
Generic Name cisplatin
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

cisplatin 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9505
Product ID 0143-9505_b463892e-6ca3-4c57-ae72-bdd3a7370a08
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075036
Listing Expiration 2026-12-31
Marketing Start 2000-11-07

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439505
Hyphenated Format 0143-9505

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 ANDA075036 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0143-9505-01) / 100 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0143-9505-01 1 VIAL, MULTI-DOSE in 1 CARTON (0143-9505-01) / 100 mL in 1 VIAL, MULTI-DOSE

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": "b463892e-6ca3-4c57-ae72-bdd3a7370a08", "openfda": {"nui": ["N0000175413", "N0000175073"], "unii": ["Q20Q21Q62J"], "rxcui": ["309311"], "spl_set_id": ["76aea034-6d58-4390-a164-36aa09c1f101"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0143-9505-01)  / 100 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0143-9505-01", "marketing_start_date": "20001107"}], "brand_name": "CISplatin", "product_id": "0143-9505_b463892e-6ca3-4c57-ae72-bdd3a7370a08", "dosage_form": "INJECTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "0143-9505", "generic_name": "Cisplatin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CISplatin", "active_ingredients": [{"name": "CISPLATIN", "strength": "1 mg/mL"}], "application_number": "ANDA075036", "marketing_category": "ANDA", "marketing_start_date": "20001107", "listing_expiration_date": "20261231"}