NITROFURANTOIN MACROCRYSTALS
NITROFURANTOIN MACROCRYSTALS
Approved
Approval ID
66474d1d-afc8-f611-e053-2a91aa0acbf5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2023
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nitrofurantoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-458
Application NumberNDA016620
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitrofurantoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2023
FDA Product Classification
INGREDIENTS (8)
NITROFURANTOINActive
Quantity: 100 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT