NDC Code(s) : 49349-576-10, 49349-576-04
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-576(NDC:0185-0122)
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
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(UNII: Z135WT9208)
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 MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONES(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color black (ivory), white (ivory) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code E122
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-576-106 in 1 BOTTLE Type 0: Not a Combination Product14/04/2016
2NDC:49349-576-0414 in 1 BLISTER PACK Type 0: Not a Combination Product14/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077066 04/14/2016

PRINCIPAL DISPLAY PANEL

DRUG: Nitrofurantoin (monohydrate/macrocrystals)

GENERIC: Nitrofurantoin (monohydrate/macrocrystals)

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 49349-576-10

NDC: 49349-576-04

COLOR: black

SHAPE: CAPSULE

SCORE: No score

SIZE: 21 mm

IMPRINT: E122

PACKAGING: 6 in 1 BOTTLE

PACKAGING: 14 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • NITROFURANTOIN 25mg in 1
  • NITROFURANTOIN MONOHYDRATE 75mg in 1

INACTIVE INGREDIENT(S):

  • CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
  • POVIDONES
  • SILICON DIOXIDE
  • MAGNESIUM STEARATE
  • STARCH, CORN
  • TALC
  • D&C YELLOW NO. 10
  • FD&C BLUE NO. 1
  • FD&C RED NO. 40
  • GELATIN
  • LACTOSE MONOHYDRATE
  • TITANIUM DIOXIDE

MM3

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