Cordran
Cordran Cream and Cordran Ointment Flurandrenolide, USP
Approved
Approval ID
a0949773-c75f-4ef0-a69c-1abd978340d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2023
Manufacturers
FDA
Almirall, LLC
DUNS: 605425912
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
flurandrenolide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16110-035
Application NumberNDA012806
Product Classification
M
Marketing Category
C73594
G
Generic Name
flurandrenolide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 13, 2023
FDA Product Classification
INGREDIENTS (9)
FLURANDRENOLIDEActive
Quantity: 0.5 mg in 1 g
Code: 8EUL29XUQT
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
flurandrenolide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16110-026
Application NumberNDA012806
Product Classification
M
Marketing Category
C73594
G
Generic Name
flurandrenolide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 13, 2023
FDA Product Classification
INGREDIENTS (5)
FLURANDRENOLIDEActive
Quantity: 0.5 mg in 1 g
Code: 8EUL29XUQT
Classification: ACTIB
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
flurandrenolide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16110-034
Application NumberNDA012806
Product Classification
M
Marketing Category
C73594
G
Generic Name
flurandrenolide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 13, 2023
FDA Product Classification
INGREDIENTS (9)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
FLURANDRENOLIDEActive
Quantity: 0.25 mg in 1 g
Code: 8EUL29XUQT
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT