Roflumilast
ROFLUMILAST TABLETS. 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
30dd6eae-6435-cae1-e063-6294a90a003b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 21, 2025
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
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 Code51407-975
Application NumberANDA212490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Roflumilast
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2025
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ROFLUMILASTActive
Quantity: 500 ug in 1 1
Code: 0P6C6ZOP5U
Classification: ACTIB