NDC 76431-210

Myalept

Metreleptin

Myalept is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Aegerion Pharmaceuticals, Inc.. The primary component is Metreleptin.

• Product ID: 76431-210_04f40de8-4c2c-4e3c-a59f-e81f276d0934
• NDC: 76431-210
• Product Type: Human Prescription Drug
• Proprietary Name: Myalept
• Generic Name: Metreleptin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-03-05
• Marketing Category: BLA / BLA
• Application Number: BLA125390
• Labeler Name: Aegerion Pharmaceuticals, Inc.
• Substance Name: METRELEPTIN
• Active Ingredient Strength: 11 mg/2.2mL
• Pharm Classes: Leptin Analog [EPC],Analogs/Derivatives [Chemical/Ingredient],Leptin [Chemical/Ingredient]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 76431-210-01

1 VIAL, GLASS in 1 CARTON (76431-210-01) > 2.2 mL in 1 VIAL, GLASS

• Marketing Start Date: 2015-03-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76431-210-01 [76431021001]

Myalept INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125390
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-05

Drug Details

Active Ingredients

Ingredient	Strength
METRELEPTIN	11.3 mg/2.2mL

OpenFDA Data

• SPL SET ID: c986f93b-855d-4ef0-b620-5d41a0513e48
• Manufacturer:
  • Aegerion Pharmaceuticals, Inc.
• UNII:
  • TL60C27RLH
• RxNorm Concept Unique ID - RxCUI:
  • 1491634
  • 1491629
• PHarm Class EPC:
  • Leptin Analog [EPC]
• NUI Code:
  • N0000190854
  • N0000175452
  • N0000170333

Pharmacological Class

• Leptin Analog [EPC]
• Analogs/Derivatives [Chemical/Ingredient]
• Leptin [Chemical/Ingredient]