Nitrofurantoin monohydrate/macrocrystals
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals)
Approved
Approval ID
74081802-b870-9430-e053-2a91aa0ac31e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nitrofurantoin monohydrate/macrocrystals
PRODUCT DETAILS
NDC Product Code68071-4535
Application NumberANDA207372
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 15, 2021
Generic NameNitrofurantoin monohydrate/macrocrystals
INGREDIENTS (27)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)Inactive
Code: K6MOM3T5YL
Classification: IACT
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
NITROFURANTOINActive
Quantity: 25 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
NITROFURANTOIN MONOHYDRATEActive
Quantity: 75 mg in 1 1
Code: E1QI2CQQ1I
Classification: ACTIM