NDC 61126-003

Platinol

Cisplatin

Platinol is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Corden Pharma Latina S.p.a.. The primary component is Cisplatin.

• Product ID: 61126-003_fd135112-4330-42bd-ac2e-d3cd6f96325d
• NDC: 61126-003
• Product Type: Human Prescription Drug
• Proprietary Name: Platinol
• Generic Name: Cisplatin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-01-13
• Marketing Category: NDA / NDA
• Application Number: NDA018057
• Labeler Name: Corden Pharma Latina S.p.A.
• Substance Name: CISPLATIN
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 61126-003-10

10 CARTON in 1 CARTON (61126-003-10) > 1 VIAL in 1 CARTON > 50 mL in 1 VIAL (61126-003-01)

• Marketing Start Date: 2012-01-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61126-003-10 [61126000310]

Platinol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA018057
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-01-13
• Marketing End Date: 2012-01-13

NDC 61126-003-01 [61126000301]

Platinol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA018057
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-01-13
• Marketing End Date: 2012-01-13

Drug Details

Active Ingredients

Ingredient	Strength
CISPLATIN	1 mg/mL

OpenFDA Data

• SPL SET ID: b2a8e240-5e93-4a58-9ba2-688a87a5e20c
• Manufacturer:
  • Corden Pharma Latina S.p.A.
• UNII:
  • Q20Q21Q62J
• RxNorm Concept Unique ID - RxCUI:
  • 1736854
  • 1736857

Pharmacological Class

• Platinum-based Drug [EPC]
• Platinum-containing Compounds [EXT]

NDC Crossover Matching brand name "Platinol" or generic name "Cisplatin"

NDC	Brand Name	Generic Name
61126-003	Platinol	cisplatin
0143-9504	CISplatin	Cisplatin
0143-9505	CISplatin	Cisplatin
0703-5747	Cisplatin	Cisplatin
0703-5748	Cisplatin	Cisplatin
16729-288	Cisplatin	Cisplatin
44567-509	CISplatin	CISplatin
44567-510	CISplatin	CISplatin
44567-511	CISplatin	CISplatin
44567-530	Cisplatin	cisplatin
47781-609	Cisplatin	cisplatin
47781-610	Cisplatin	cisplatin
63323-103	Cisplatin	CISPLATIN
68001-283	Cisplatin	Cisplatin
68083-162	CISPLATIN	Cisplatin
68083-163	CISPLATIN	Cisplatin
70860-206	Cisplatin	cisplatin
61126-004	Platinol-AQ	cisplatin