Macrilen
These highlights do not include all the information needed to use MACRILEN safely and effectively. See full prescribing information for MACRILEN.MACRILEN (macimorelin) for oral solution Initial U.S. Approval: 2017
Approved
Approval ID
6034c9b8-5a36-4961-a5dd-11ebf7bdab78
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2021
Manufacturers
FDA
Novo Nordisk
DUNS: 622920320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Macimorelin acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-1401
Application NumberNDA205598
Product Classification
M
Marketing Category
C73594
G
Generic Name
Macimorelin acetate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (6)
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MACIMORELINActive
Quantity: 60 mg in 1 mg
Code: 8680B21W73
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT