NDC 16729-288

Cisplatin

Cisplatin

Cisplatin is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare, Inc.. The primary component is Cisplatin.

• Product ID: 16729-288_43a22af4-12fc-640e-e054-00144ff88e88
• NDC: 16729-288
• Product Type: Human Prescription Drug
• Proprietary Name: Cisplatin
• Generic Name: Cisplatin
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-12-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206774
• Labeler Name: Accord Healthcare, Inc.
• 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 16729-288-11

50 mL in 1 VIAL (16729-288-11)

• Marketing Start Date: 2016-12-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16729-288-38 [16729028838]

Cisplatin INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206774
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-12-13

NDC 16729-288-11 [16729028811]

Cisplatin INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206774
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-12-13

Drug Details

Active Ingredients

Ingredient	Strength
CISPLATIN	1 mg/mL

OpenFDA Data

• SPL SET ID: b2b029f5-0d7e-4e7f-accc-b722aec34c68
• Manufacturer:
  • Accord Healthcare, Inc.
• 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