NDC 62064-122

TROGARZO

Ibalizumab

TROGARZO is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Theratechnologies Inc.. The primary component is Ibalizumab.

• Product ID: 62064-122_10893acf-e65a-4ebf-82a6-d22ee4774a06
• NDC: 62064-122
• Product Type: Human Prescription Drug
• Proprietary Name: TROGARZO
• Generic Name: Ibalizumab
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-04-20
• Marketing Category: BLA / BLA
• Application Number: BLA761065
• Labeler Name: Theratechnologies Inc.
• Substance Name: IBALIZUMAB
• Active Ingredient Strength: 150 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 62064-122-02

2 VIAL, SINGLE-USE in 1 CARTON (62064-122-02) > 1.33 mL in 1 VIAL, SINGLE-USE (62064-122-01)

• Marketing Start Date: 2018-04-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62064-122-02 [62064012202]

TROGARZO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761065
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-04-20

NDC 62064-122-01 [62064012201]

TROGARZO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761065
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-04-20

Drug Details

Active Ingredients

Ingredient	Strength
IBALIZUMAB	150 mg/mL

OpenFDA Data

• SPL SET ID: c548ad82-9d1f-4d16-95b6-4e6106badf43
• Manufacturer:
  • Theratechnologies Inc.
• UNII:
  • LT369U66CE
• RxNorm Concept Unique ID - RxCUI:
  • 2043317
  • 2043322