Imiquimod
These highlights do not include all the information needed to use Imiquimod Cream safely and effectively. See full prescribing information for Imiquimod Cream. Imiquimod Cream, 5%For topical use onlyInitial U.S. Approval: 1997
Approved
Approval ID
1505cf54-37da-4b2b-9812-6ffd6a01a7c7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2022
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Imiquimod
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45802-368
Application NumberANDA078837
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imiquimod
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 31, 2018
FDA Product Classification
INGREDIENTS (14)
IMIQUIMODActive
Quantity: 12.5 mg in 0.25 g
Code: P1QW714R7M
Classification: ACTIB
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT