NDC Code(s) : 69189-3658-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nitrofurantoin monohydrate macrocrystalsNitrofurantoin monohydrate macrocrystals CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-3658(NDC:0591-3658)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN MONOHYDRATE(UNII: E1QI2CQQ1I)
(NITROFURANTOIN - UNII:927AH8112L) 		NITROFURANTOIN75 mg
NITROFURANTOIN(UNII: 927AH8112L)
(NITROFURANTOIN - UNII:927AH8112L) 		NITROFURANTOIN25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POVIDONE(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
CARBOMER HOMOPOLYMER TYPE A(UNII: F68VH75CJC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color GRAY (opaque grey body), BLACK (opaque black cap) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code WATSON;3658
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-3658-11 in 1 DOSE PACK Type 0: Not a Combination Product28/03/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202250 03/28/2016

PRINCIPAL DISPLAY PANEL

Nitrofurantoin Mono/Macro 100 mg capsule