Nitrofurantion
Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only
Approved
Approval ID
d8c68797-47a9-2956-e053-2a95a90a0149
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2022
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.
Nitrofurantion
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-2647
Application NumberANDA201722
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitrofurantion
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2022
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
NITROFURANTOINActive
Quantity: 100 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT