Nitrofurantoin Macrocrystals (Page 5 of 5)

Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 9777402, Israel
Distributed by:
Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807
Rev. 03-2019-00

PRINCIPAL DISPLAY PANEL

DRUG: Nitrofurantoin Macrocrystals

GENERIC: Nitrofurantoin Macrocrystals

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-2602-0

COLOR: pink

SHAPE: CAPSULE

SCORE: No score

SIZE: 18 mm

IMPRINT: Z;Zenith;100mg;2131

PACKAGING: 14 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • NITROFURANTOIN 100mg in 1

INACTIVE INGREDIENT(S):

  • D&C RED NO. 33
  • GELATIN
  • SHELLAC
  • LACTOSE MONOHYDRATE
  • PROPYLENE GLYCOL
  • TALC
  • TITANIUM DIOXIDE
  • FD&C RED NO. 40
  • ALUMINUM OXIDE
  • D&C YELLOW NO. 10
  • FERROSOFERRIC OXIDE
  • INDIGOTINDISULFONATE SODIUM
  • FD&C BLUE NO. 1
  • FD&C BLUE NO. 2
  • STARCH, CORN
Remedy_Label
(click image for full-size original)
NITROFURANTOIN MACROCRYSTALS
nitrofurantoin macrocrystals capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2602(NDC:0115-1645)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN (NITROFURANTOIN) NITROFURANTOIN 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
GELATIN
LACTOSE MONOHYDRATE
TALC
TITANIUM DIOXIDE
D&C RED NO. 33
Product Characteristics
Color pink Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Z;Zenith;100mg;2131
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2602-0 14 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073652 02/26/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 03/2020 REMEDYREPACK INC.

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