MedPath

Bactroban

BACTROBAN CREAM®(mupirocin calcium cream, 2%)For Dermatologic Use

Approved
Approval ID

87734c71-a574-465d-b941-f993f9ae8b2b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 13, 2007

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-4642
Application NumberNDA050746
Product Classification
M
Marketing Category
C73594
G
Generic Name
mupirocin calcium
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2010
FDA Product Classification

INGREDIENTS (9)

CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
MUPIROCIN CALCIUMActive
Quantity: 20 mg in 1 g
Code: RG38I2P540
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Bactroban - FDA Drug Approval Details