NDC 15054-1040

Increlex

Mecasermin

Increlex is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ipsen Biopharmaceuticals, Inc.. The primary component is Mecasermin.

• Product ID: 15054-1040_105b67a0-a2b2-447b-a233-ab693d9d6fd5
• NDC: 15054-1040
• Product Type: Human Prescription Drug
• Proprietary Name: Increlex
• Generic Name: Mecasermin
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2006-01-03
• Marketing Category: BLA / NDA
• Application Number: BLA021839
• Labeler Name: Ipsen Biopharmaceuticals, Inc.
• Substance Name: MECASERMIN
• Active Ingredient Strength: 40 mg/4mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 15054-1040-5

1 VIAL, MULTI-DOSE in 1 CARTON (15054-1040-5) > 4 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2006-01-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 15054-1040-5 [15054104005]

Increlex INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021839
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-01-03

Drug Details

Active Ingredients

Ingredient	Strength
MECASERMIN	40 mg/4mL

OpenFDA Data

• SPL SET ID: a8b27a1b-a611-4f91-ad22-76d4b390c3ae
• Manufacturer:
  • Ipsen Biopharmaceuticals, Inc.
• UNII:
  • 7GR9I2683O
• RxNorm Concept Unique ID - RxCUI:
  • 615882
  • 604806