NDC 72152-547

Zulresso

Brexanolone

Zulresso is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sage Therapeutics, Inc.. The primary component is Brexanolone.

• Product ID: 72152-547_4a180131-3d52-4b37-892e-f3f6ff032540
• NDC: 72152-547
• Product Type: Human Prescription Drug
• Proprietary Name: Zulresso
• Generic Name: Brexanolone
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-06-17
• Marketing Category: NDA / NDA
• Application Number: NDA211371
• Labeler Name: Sage Therapeutics, Inc.
• Substance Name: BREXANOLONE
• Active Ingredient Strength: 5 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 72152-547-20

1 VIAL, SINGLE-DOSE in 1 CARTON (72152-547-20) > 20 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-06-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72152-547-20 [72152054720]

Zulresso INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA211371
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-06-17

Drug Details

Active Ingredients

Ingredient	Strength
BREXANOLONE	5 mg/mL

OpenFDA Data

• SPL SET ID: b40f3b2a-1859-4ed6-8551-444300806d13
• Manufacturer:
  • Sage Therapeutics, Inc.
• UNII:
  • S39XZ5QV8Y
• RxNorm Concept Unique ID - RxCUI:
  • 2121786
  • 2121781
• UPC Code:
  • 0372152547208