Nitrofurantion Macrocrystals (Page 4 of 4)

HOW SUPPLIED

100 mg opaque, yellow capsule imprinted with “MACRODANTIN 100 mg” and “52427-288”.

NDC: 70518-0103-00

NDC: 70518-0103-01

NDC: 70518-0103-02

PACKAGING: 10 in 1 BOTTLE PLASTIC

PACKAGING: 20 in 1 BOTTLE PLASTIC
PACKAGING: 10 in 1 BOTTLE PLASTIC
PACKAGING: 14 in 1 BOTTLE PLASTIC

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: nitrofurantoin macrocrystals

GENERIC: nitrofurantoin macrocrystals

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-0103-0

NDC: 70518-0103-1

NDC: 70518-0103-2

COLOR: yellow

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: MACRODANTIN;100;mg;52427;288

PACKAGING: 10 in 1 BOTTLE, PLASTIC

PACKAGING: 20 in 1 BOTTLE PLASTIC

PACKAGING: 14 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • NITROFURANTOIN 100mg in 1

INACTIVE INGREDIENT(S):

  • GELATIN, UNSPECIFIED
  • LACTOSE, UNSPECIFIED FORM
  • TALC
  • STARCH, CORN
  • D&C YELLOW NO. 10
  • FD&C YELLOW NO. 6
  • TITANIUM DIOXIDE
MM1
(click image for full-size original)
MM3
(click image for full-size original)
NITROFURANTION MACROCRYSTALS
nitrofurantion macrocrystals capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0103(NDC:47781-308)
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
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow (opaque) Score no score
Shape CAPSULE (capsule) Size 14mm
Flavor Imprint Code MACRODANTIN;100;mg;52427;288
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0103-0 10 CAPSULE in 1 BOTTLE None
2 NDC:70518-0103-1 20 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:70518-0103-2 14 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016620 01/05/2017
Labeler — REMEDYREPACK INC. (829572556)

Revised: 01/2024 REMEDYREPACK INC.

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