rifampin
Rifampin Capsules USP
Approved
Approval ID
6d1c87df-b319-4c63-9f19-6584d7c4ff8e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rifampin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70518-2404
Application NumberANDA090034
Product Classification
M
Marketing Category
C73584
G
Generic Name
rifampin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (13)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RIFAMPINActive
Quantity: 300 mg in 1 1
Code: VJT6J7R4TR
Classification: ACTIB