Mycobutin
Mycobutin (Rifabutin) Capsules, USP
Approved
Approval ID
2e050d5e-3175-2c6d-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2016
Manufacturers
FDA
Department of State Health Services, Pharmacy Branch
DUNS: 781992540
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rifabutin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55695-010
Application NumberNDA050689
Product Classification
M
Marketing Category
C73594
G
Generic Name
rifabutin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2016
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RIFABUTINActive
Quantity: 150 mg in 1 1
Code: 1W306TDA6S
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT