rifabutin
Rifabutin Capsules USP, 150 mg Rx only
Approved
Approval ID
4be9cc3f-0016-4426-a700-574b45ce245b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code68180-285
Application NumberANDA090033
Product Classification
M
Marketing Category
C73584
G
Generic Name
rifabutin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (11)
RIFABUTINActive
Quantity: 150 mg in 1 1
Code: 1W306TDA6S
Classification: ACTIB
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT