0591-3658 : Nitrofurantoin Monohydrate Macrocrystals Oral Capsule

NDC:	0591-3658
Labeler:	Actavis Pharma, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Nitrofurantoin Monohydrate Macrocrystals
Dosage Form:	Oral Capsule
Application #:	ANDA202250
Rev. Date:	Nov 13, 2015

Appearance:

Markings:	WATSON;3658
Shapes:	Capsule
Colors:	Gray / Black
Size (mm):	19
Segments: ^*	1
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

0591-3658-01: 100 CAPSULE IN 1 BOTTLE (0591‑3658‑01)
0591-3658-10: 1000 CAPSULE IN 1 BOTTLE (0591‑3658‑10)
0591-3658-30: 30 CAPSULE IN 1 BOTTLE (0591‑3658‑30)

Active Ingredients:

Nitrofurantoin Monohydrate
Nitrofurantoin

Dosage Strength:

75 mg
25 mg

Inactive Ingredients:

Lactose Monohydrate
Povidones
Starch, Corn
Silicon Dioxide
Talc
Magnesium Stearate
Fd&c Red No. 40
Fd&c Blue No. 1
D&c Red No. 28
Fd&c Yellow No. 6
Fd&c Red No. 3
Titanium Dioxide
Gelatin
Carbomer Homopolymer Type a (Allyl Pentaerythritol Crosslinked)
Shellac
Alcohol
Isopropyl Alcohol
Butyl Alcohol
Propylene Glycol
Ammonia
Ferrosoferric Oxide
Potassium Hydroxide
Water

Pharmaceutical Classes:

Nitrofuran Antibacterial [EPC]
Nitrofurans [Chemical/Ingredient]

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.