Nitrofurantoin Macrocrystals (Page 4 of 4)

HOW SUPPLIED

Nitrofurantoin macrocrystals capsules is available as follows:

25 mg opaque, white capsule imprinted with “MACRODANTIN 25 mg” and “52427-286”.

NDC 47781-306-01 bottle of 100

50 mg opaque, yellow and white capsule imprinted with “MACRODANTIN 50 mg” and “52427-287”.

NDC 47781-307-01 bottle of 100

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

NDC 47781-308-01 bottle of 100

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.

Distributed by: Alvogen, Inc.
Morristown, NJ 07960 USA

Rev: 09/2019 PI306-07

NDC 47781-306 -01

Nitrofurantoin
Macrocrystals
Capsules

25 mg

Rx only

100 Capsules

Alvogen®

nitrofurantoin-macrocrystals-lbl-25-mg
(click image for full-size original)

NDC 47781-307 -01

Nitrofurantoin
Macrocrystals
Capsules

50 mg

Rx only

100 Capsules

Alvogen®

nitrofurantoin-macrocrystals-lbl-50-mg
(click image for full-size original)

NDC 47781-308 -01

Nitrofurantoin
Macrocrystals
Capsules

100 mg

Rx only

100 Capsules

Alvogen®

nitrofurantoin-macrocrystals-lbl-100-mg
(click image for full-size original)
NITROFURANTOIN MACROCRYSTALS
nitrofurantoin macrocrystals capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-306
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN (NITROFURANTOIN) NITROFURANTOIN 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (opaque) Score no score
Shape CAPSULE (capsule) Size 14mm
Flavor Imprint Code MACRODANTIN;25;mg;52427;286
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47781-306-01 100 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016620 09/27/2010
NITROFURANTOIN MACROCRYSTALS
nitrofurantoin macrocrystals capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-307
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN (NITROFURANTOIN) NITROFURANTOIN 50 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) , WHITE (opaque) Score no score
Shape CAPSULE (capsule) Size 14mm
Flavor Imprint Code MACRODANTIN;50;mg;52427;287
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47781-307-01 100 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016620 09/27/2010
NITROFURANTOIN MACROCRYSTALS
nitrofurantoin macrocrystals capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:47781-308-01 100 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016620 09/27/2010
Labeler — Alvogen Inc. (008057330)

Revised: 11/2019 Alvogen Inc.

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