NDC 68875-0103

Gattex

Teduglutide

Gattex is a Kit in the Human Prescription Drug category. It is labeled and distributed by Shire-nps Pharmaceuticals, Inc.. The primary component is .

• Product ID: 68875-0103_008b6d52-ee4e-466e-a4be-8f3ce9b4bdcb
• NDC: 68875-0103
• Product Type: Human Prescription Drug
• Proprietary Name: Gattex
• Generic Name: Teduglutide
• Dosage Form: Kit
• Marketing Start Date: 2012-12-21
• Marketing Category: NDA / NDA
• Application Number: NDA203441
• Labeler Name: Shire-NPS Pharmaceuticals, Inc.
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68875-0103-1

1 KIT in 1 CARTON (68875-0103-1) * .5 mL in 1 SYRINGE, PLASTIC * .7 mL in 1 PACKET * .5 mL in 1 VIAL (68875-0101-1)

• Marketing Start Date: 2012-12-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68875-0103-1 [68875010301]

Gattex KIT

• Marketing Category: NDA
• Application Number: NDA203441
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-21

Drug Details

OpenFDA Data

• SPL SET ID: 66b69c1e-b25c-44d3-b5ff-1c1de9a516fa
• Manufacturer:
  • Shire-NPS Pharmaceuticals, Inc.
• UNII:
  • 7M19191IKG
• RxNorm Concept Unique ID - RxCUI:
  • 1489307
  • 1364472
  • 1364477
• PHarm Class EPC:
  • GLP-2 Analog [EPC]
• NUI Code:
  • N0000175140
  • N0000175452
  • N0000190990
  • N0000190992

NDC Crossover Matching brand name "Gattex" or generic name "Teduglutide"

NDC	Brand Name	Generic Name
68875-0101	Gattex	teduglutide
68875-0102	Gattex	teduglutide
68875-0103	Gattex	teduglutide