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
f25a0230-3cf6-4366-bebe-0ea5ff8de5ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2023
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 2
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 Code31722-623
Application NumberANDA208213
Product Classification
M
Marketing Category
C73584
G
Generic Name
Roflumilast
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
ROFLUMILASTActive
Quantity: 500 ug in 1 1
Code: 0P6C6ZOP5U
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Roflumilast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-676
Application NumberANDA208213
Product Classification
M
Marketing Category
C73584
G
Generic Name
Roflumilast
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0A
Classification: IACT
ROFLUMILASTActive
Quantity: 250 ug in 1 1
Code: 0P6C6ZOP5U
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT