NDC 72126-007

Tegsedi

Inotersen

Tegsedi is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Akcea Therapeutics, Inc.. The primary component is Inotersen Sodium.

• Product ID: 72126-007_096941de-9387-47b2-b717-918d2709ed37
• NDC: 72126-007
• Product Type: Human Prescription Drug
• Proprietary Name: Tegsedi
• Generic Name: Inotersen
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-10-05
• Marketing Category: NDA / NDA
• Application Number: NDA211172
• Labeler Name: Akcea Therapeutics, Inc.
• Substance Name: INOTERSEN SODIUM
• Active Ingredient Strength: 284 mg/1.5mL
• Pharm Classes: Antisense Oligonucleotide [EPC], Decreased RNA Integrity [PE], Increased Protein Breakdown [PE], Oligonucleotides, Antisense [CS], Transthyretin-directed RNA Interaction [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 72126-007-01

4 TRAY in 1 CARTON (72126-007-01) > 1 SYRINGE in 1 TRAY (72126-007-02) > 1.5 mL in 1 SYRINGE

• Marketing Start Date: 2018-10-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72126-007-02 [72126000702]

Tegsedi INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA211172
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-05

NDC 72126-007-01 [72126000701]

Tegsedi INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA211172
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-05

Drug Details

Active Ingredients

Ingredient	Strength
INOTERSEN SODIUM	284 mg/1.5mL

OpenFDA Data

• SPL SET ID: 8513207e-b55f-417b-9473-af785146a543
• Manufacturer:
  • Akcea Therapeutics, Inc.
• UNII:
  • 950736UC77
• RxNorm Concept Unique ID - RxCUI:
  • 2099323
  • 2099318
• UPC Code:
  • 0372126007011