NDC 64011-701

Vyleesi

Bremelanotide

Vyleesi is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Amag Pharmaceuticals, Inc.. The primary component is Bremelanotide Acetate.

• Product ID: 64011-701_2fa95781-814b-4e03-a2c9-7b58734d5987
• NDC: 64011-701
• Product Type: Human Prescription Drug
• Proprietary Name: Vyleesi
• Generic Name: Bremelanotide
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-06-21
• Marketing Category: NDA / NDA
• Application Number: NDA210557
• Labeler Name: AMAG Pharmaceuticals, Inc.
• Substance Name: BREMELANOTIDE ACETATE
• Active Ingredient Strength: 2 mg/.3mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 64011-701-04

4 SYRINGE in 1 CARTON (64011-701-04) > .3 mL in 1 SYRINGE (64011-701-01)

• Marketing Start Date: 2019-06-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64011-701-04 [64011070104]

Vyleesi INJECTION

• Marketing Category: NDA
• Application Number: NDA210557
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-06-21

NDC 64011-701-12 [64011070112]

Vyleesi INJECTION

• Marketing Category: NDA
• Application Number: NDA210557
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-09

NDC 64011-701-01 [64011070101]

Vyleesi INJECTION

• Marketing Category: NDA
• Application Number: NDA210557
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-06-21

Drug Details

Active Ingredients

Ingredient	Strength
BREMELANOTIDE ACETATE	1.75 mg/.3mL

OpenFDA Data

• SPL SET ID: 9146ae05-918b-483e-b86d-933485ce36eb
• Manufacturer:
  • AMAG Pharmaceuticals, Inc.
• UNII:
  • PV2WI7495P
• RxNorm Concept Unique ID - RxCUI:
  • 2176316
  • 2176321

NDC Crossover Matching brand name "Vyleesi" or generic name "Bremelanotide"

NDC	Brand Name	Generic Name
64011-701	Vyleesi	bremelanotide
80064-141	Vyleesi	bremelanotide