Nitrofurantoin monohydrate/ macrocrystalline capsule

Ingredients and appearance - Product information

Nitrofurantoin monohydrate/ macrocrystalline capsule- Nitrofurantoin monohydrate/macrocrystalline

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 33261-160
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nitrofurantoin ( UNII: 927AH8112L)( Nitrofurantoin - UNII: 927AH8112L ) 25 mgin 1
Nitrofurantoin monohydrate ( UNII: E1QI2CQQ1I)( Nitrofurantoin - UNII: 927AH8112L ) 75 mgin 1

Inactive Ingredients

Ingredient Name Code
Carbomer homopolymer type b (allyl sucrose crosslinked) ( UNII: Z135WT9208)
Starch, corn ( UNII: O8232NY3SJ)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Gelatin ( UNII: 2G86QN327L)
Lactose ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Povidones ( UNII: FZ989GH94E)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color BLACK Imprint Code Macrobid;52427285
Score 1 Shape CAPSULE
Size 20 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA020064 USA

Labeler - Aidarex Pharmaceuticals LLC( 801503249)