NDC 63323-103

Cisplatin

Cisplatin

Cisplatin is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Cisplatin.

• Product ID: 63323-103_1355b932-bdb6-4c06-b2db-b8dfdd0d6c6a
• NDC: 63323-103
• Product Type: Human Prescription Drug
• Proprietary Name: Cisplatin
• Generic Name: Cisplatin
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2000-09-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074735
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: CISPLATIN
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63323-103-51

1 VIAL in 1 CARTON (63323-103-51) > 50 mL in 1 VIAL

• Marketing Start Date: 2000-09-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-103-64 [63323010364]

Cisplatin INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074735
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-09-05

NDC 63323-103-65 [63323010365]

Cisplatin INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074735
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-09-05

NDC 63323-103-51 [63323010351]

Cisplatin INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074735
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-09-05

Drug Details

Active Ingredients

Ingredient	Strength
CISPLATIN	1 mg/mL

OpenFDA Data

• SPL SET ID: de6302d5-85f0-4116-a709-57826c2c84fe
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • Q20Q21Q62J
• RxNorm Concept Unique ID - RxCUI:
  • 309311

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
61126-003	Platinol	cisplatin
61126-004	Platinol-AQ	cisplatin