BACTROBAN
BACTROBAN CREAM (mupirocin calcium cream, 2%)For Dermatologic Use
Approved
Approval ID
76bdab9d-9153-4db6-9b9a-ff376374a8ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MUPIROCIN CALCIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-028
Application NumberNDA050746
Product Classification
M
Marketing Category
C73594
G
Generic Name
MUPIROCIN CALCIUM
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 6, 2011
FDA Product Classification
INGREDIENTS (9)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
MUPIROCIN CALCIUMActive
Quantity: 20 mg in 1 g
Code: RG38I2P540
Classification: ACTIB
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT