Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (Monohydrate/Macrocrystals) Capsules (Twice-a-day Dosage)
Approved
Approval ID
047e8b1b-8888-40b7-b593-434e92eb333c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-300
Application NumberANDA080043
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitrofurantoin (monohydrate/macrocrystals)
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2010
FDA Product Classification
INGREDIENTS (14)
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
NITROFURANTOINActive
Quantity: 25 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
NITROFURANTOIN MONOHYDRATEActive
Quantity: 75 mg in 1 1
Code: E1QI2CQQ1I
Classification: ACTIB