Increlex
These highlights do not include all the information needed to use INCRELEX safely and effectively. See full prescribing information for INCRELEX. INCRELEX (mecasermin) injection, for subcutaneous use Initial U.S. Approval: 2005
Approved
Approval ID
d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Eton Pharmaceuticals, Inc.
DUNS: 080870465
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mecasermin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71863-216
Application NumberBLA021839
Product Classification
M
Marketing Category
C73585
G
Generic Name
Mecasermin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (7)
MecaserminActive
Quantity: 40 mg in 4 mL
Code: 7GR9I2683O
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 36 mg in 4 mL
Code: LKG8494WBH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT