NDC 68875-0101

Gattex

Teduglutide

Gattex is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Shire-nps Pharmaceuticals, Inc.. The primary component is Teduglutide.

• Product ID: 68875-0101_008b6d52-ee4e-466e-a4be-8f3ce9b4bdcb
• NDC: 68875-0101
• Product Type: Human Prescription Drug
• Proprietary Name: Gattex
• Generic Name: Teduglutide
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2012-12-21
• Marketing Category: NDA / NDA
• Application Number: NDA203441
• Labeler Name: Shire-NPS Pharmaceuticals, Inc.
• Substance Name: TEDUGLUTIDE
• Active Ingredient Strength: 5 mg/.5mL
• Pharm Classes: GLP-2 Analog [EPC],Glucagon-like Peptide-2 (GLP-2) Agonists [MoA],Glucagon-Like Peptide 2 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68875-0101-2

30 VIAL in 1 CARTON (68875-0101-2) > .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 68875-0101-4 [68875010104]

Gattex INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA203441
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-12-21
• Marketing End Date: 2013-01-16

NDC 68875-0101-1 [68875010101]

Gattex INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA203441
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-16

NDC 68875-0101-2 [68875010102]

Gattex INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

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

Drug Details

Active Ingredients

Ingredient	Strength
TEDUGLUTIDE	5 mg/.5mL

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

Pharmacological Class

• GLP-2 Analog [EPC]
• Glucagon-like Peptide-2 (GLP-2) Agonists [MoA]
• Glucagon-Like Peptide 2 [Chemical/Ingredient]
• Analogs/Derivatives [Chemical/Ingredient]

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