Nitrofurantoin Mono
Nitrofurantoin Mono
Approved
Approval ID
d9840719-271f-42a9-a5c9-3e039ec8fbac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2022
Manufacturers
FDA
PharmPak, Inc.
DUNS: 175493840
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NITROFURANTOIN MONOHYDRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54348-849
Application NumberNDA020064
Product Classification
M
Marketing Category
C73594
G
Generic Name
NITROFURANTOIN MONOHYDRATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2022
FDA Product Classification
INGREDIENTS (14)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NITROFURANTOINActive
Quantity: 25 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
NITROFURANTOIN MONOHYDRATEActive
Quantity: 75 mg in 1 1
Code: E1QI2CQQ1I
Classification: ACTIM