NDC 10122-620

KENGREAL

Cangrelor

KENGREAL is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Chiesi Usa, Inc.. The primary component is Cangrelor.

• Product ID: 10122-620_17ff4f7d-5a56-4086-ad85-09918cce3dd0
• NDC: 10122-620
• Product Type: Human Prescription Drug
• Proprietary Name: KENGREAL
• Generic Name: Cangrelor
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-07-08
• Marketing Category: NDA / NDA
• Application Number: NDA204958
• Labeler Name: Chiesi USA, Inc.
• Substance Name: CANGRELOR
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: P2Y12 Platelet Inhibitor [EPC],Decreased Platelet Aggregation [PE],P2Y12 Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10122-620-10

10 VIAL, SINGLE-USE in 1 CARTON (10122-620-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (10122-620-01)

• Marketing Start Date: 2015-07-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10122-620-10 [10122062010]

KENGREAL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA204958
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-08

NDC 10122-620-01 [10122062001]

KENGREAL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA204958
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-08

Drug Details

Active Ingredients

Ingredient	Strength
CANGRELOR	50 mg/1

OpenFDA Data

• SPL SET ID: 88b434fa-8891-4fd5-9d86-7ea64667c08f
• Manufacturer:
  • Chiesi USA, Inc.
• UNII:
  • 6AQ1Y404U7
• RxNorm Concept Unique ID - RxCUI:
  • 1656061
  • 1656056

Pharmacological Class

• P2Y12 Platelet Inhibitor [EPC]
• Decreased Platelet Aggregation [PE]
• P2Y12 Receptor Antagonists [MoA]

NDC Crossover Matching brand name "KENGREAL" or generic name "Cangrelor"

NDC	Brand Name	Generic Name
10122-620	KENGREAL	cangrelor
65293-003	KENGREAL	cangrelor