Nitrofurantoin Monohydrate/ Macrocrystalline
Nitrofurantoin Monohydrate/Macrocrystals Capsule
Approved
Approval ID
e5b36fbf-4db1-43b3-bf04-39022f74d0b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 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/Macrocrystalline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-064
Application NumberNDA020064
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitrofurantoin Monohydrate/Macrocrystalline
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2011
FDA Product Classification
INGREDIENTS (13)
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
NITROFURANTOINActive
Quantity: 25 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NITROFURANTOIN MONOHYDRATEActive
Quantity: 75 mg in 1 1
Code: E1QI2CQQ1I
Classification: ACTIB