NITROFURANTOIN MACROCRYSTALS
NITROFURANTOIN CAPSULES USP (Macrocrystals)Rx only21302131
Approved
Approval ID
fb4c9c55-63c4-4d8a-b89e-36e921b39e81
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NITROFURANTOIN MACROCRYSTALS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-380
Application NumberANDA073652
Product Classification
M
Marketing Category
C73584
G
Generic Name
NITROFURANTOIN MACROCRYSTALS
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2011
FDA Product Classification
INGREDIENTS (15)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
NITROFURANTOINActive
Quantity: 100 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT