LAMPIT
These highlights do not include all the information needed to use LAMPIT safely and effectively. See full prescribing information for LAMPIT.LAMPIT (nifurtimox) tablets, for oral useInitial U.S. Approval: 2020
Approved
Approval ID
90d09714-a8b1-4696-8ada-f99dc54d0721
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 2, 2023
Manufacturers
FDA
Bayer Healthcare Pharmaceuticals INC.
DUNS: 005436809
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nifurtimox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-750
Application NumberNDA213464
Product Classification
M
Marketing Category
C73594
G
Generic Name
nifurtimox
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2020
FDA Product Classification
INGREDIENTS (6)
NIFURTIMOXActive
Quantity: 30 mg in 1 1
Code: M84I3K7C2O
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
nifurtimox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-751
Application NumberNDA213464
Product Classification
M
Marketing Category
C73594
G
Generic Name
nifurtimox
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2020
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
NIFURTIMOXActive
Quantity: 120 mg in 1 1
Code: M84I3K7C2O
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT