Mupirocin

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Encube Ethicals Private Limited

DUNS Number

725076298

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

21922-029

Application Number

ANDA213076

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

August 31, 2021

Ingredients

GLYCERYL MONO AND DIPALMITOSTEARATEInactive

Code: KC98RO82HJClass: IACT

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACT

POLYOXYL 20 CETOSTEARYL ETHERInactive

Code: YRC528SWUYClass: IACT

MINERAL OILInactive

Code: T5L8T28FGPClass: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3TClass: IACT

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

Code: RG38I2P540Class: ACTIMQuantity: 2 g in 100 g

WATERInactive

Code: 059QF0KO0RClass: IACT