cisplatin

Generic: cisplatin

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cisplatin
Generic Name cisplatin
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cisplatin 1 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-162
Product ID 68083-162_89007399-3c34-40d2-8068-a0b8e09cbef8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207323
Listing Expiration 2026-12-31
Marketing Start 2017-04-03

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083162
Hyphenated Format 68083-162

Supplemental Identifiers

RxCUI
309311
UPC
0368083162016 0368083163013
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 ANDA207323 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-162-01) / 50 mL in 1 VIAL
source: ndc

Packages (1)

68083-162-01 1 VIAL in 1 CARTON (68083-162-01) / 50 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": "89007399-3c34-40d2-8068-a0b8e09cbef8", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0368083162016", "0368083163013"], "unii": ["Q20Q21Q62J"], "rxcui": ["309311"], "spl_set_id": ["a32820f7-9ff6-4c13-a96a-4483a943fe82"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-162-01)  / 50 mL in 1 VIAL", "package_ndc": "68083-162-01", "marketing_start_date": "20170403"}], "brand_name": "CISPLATIN", "product_id": "68083-162_89007399-3c34-40d2-8068-a0b8e09cbef8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "68083-162", "generic_name": "Cisplatin", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CISPLATIN", "active_ingredients": [{"name": "CISPLATIN", "strength": "1 mg/mL"}], "application_number": "ANDA207323", "marketing_category": "ANDA", "marketing_start_date": "20170403", "listing_expiration_date": "20261231"}