Roflumilast
These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
913f1b95-9c46-40d5-a6e9-cff2e5e07eaa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Roflumilast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-786
Application NumberANDA208213
Product Classification
M
Marketing Category
C73584
G
Generic Name
Roflumilast
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ROFLUMILASTActive
Quantity: 500 ug in 1 1
Code: 0P6C6ZOP5U
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT