Mupirocin
These highlights do not include all the information needed to use MUPIROCIN CREAM safely and effectively. See full prescribing information for MUPIROCIN CREAM. MUPIROCIN cream, for topical use Initial U.S. Approval: 1987
Approved
Approval ID
b9aa01e5-a8a0-40f6-880c-5354bc5af31a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2023
Manufacturers
FDA
Gabar Health Sciences Corp.
DUNS: 118401847
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mupirocin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82429-311
Application NumberANDA213076
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mupirocin
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (8)
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
GLYCERYL MONO AND DIPALMITOSTEARATEInactive
Code: KC98RO82HJ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MUPIROCIN CALCIUMActive
Quantity: 2 g in 100 g
Code: RG38I2P540
Classification: ACTIM