NDC 51167-113

SYMDEKO

Tezacaftor And Ivacaftor

SYMDEKO is a Kit in the Human Prescription Drug category. It is labeled and distributed by Vertex Pharmaceuticals Incorporated. The primary component is .

• Product ID: 51167-113_337f8af4-fe32-4a14-829b-8c5ea207d893
• NDC: 51167-113
• Product Type: Human Prescription Drug
• Proprietary Name: SYMDEKO
• Generic Name: Tezacaftor And Ivacaftor
• Dosage Form: Kit
• Marketing Start Date: 2019-06-14
• Marketing Category: NDA / NDA
• Application Number: NDA210491
• Labeler Name: Vertex Pharmaceuticals Incorporated
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 51167-113-01

1 KIT in 1 CARTON (51167-113-01) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2019-06-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51167-113-01 [51167011301]

SYMDEKO KIT

• Marketing Category: NDA
• Application Number: NDA210491
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-21

Drug Details

OpenFDA Data

• SPL SET ID: 302ae804-37db-44fd-ac2f-3dbdeda9aa4b
• Manufacturer:
  • Vertex Pharmaceuticals Incorporated
• RxNorm Concept Unique ID - RxCUI:
  • 1999387
  • 2174390
  • 1243046
  • 2174388
  • 2174389
  • 2174387

NDC Crossover Matching brand name "SYMDEKO" or generic name "Tezacaftor And Ivacaftor"

NDC	Brand Name	Generic Name
51167-113	SYMDEKO	Tezacaftor and Ivacaftor
51167-661	SYMDEKO	Tezacaftor and Ivacaftor