Esbriet
These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET (pirfenidone) capsules, for oral useInitial U.S. Approval: 2014
Approved
Approval ID
0ab861c2-d5ca-4f92-854c-6477971a1b38
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2014
Manufacturers
FDA
InterMune, Inc.
DUNS: 035491294
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pirfenidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64116-121
Application NumberNDA022535
Product Classification
M
Marketing Category
C73594
G
Generic Name
pirfenidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2014
FDA Product Classification
INGREDIENTS (1)
PIRFENIDONEActive
Quantity: 267 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB