ONDANSETRON HCL tablet, coated

Ondansetron HCL by

Drug Labeling and Warnings

Ondansetron HCL by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals, Northwind Pharmceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NDC: 51655-400-43

MFG: 63304-458-30

Ondansetron 4 MG

3 Tablets

RX Only

Dosage: See package insert

Store at 68 to 77 degrees F.

Keep out of the reach of children.

Each film-coated tablet contains 5 mg of ondansetron hydrochloride, USP equivalent to 4 mg of ondansetron.

Mfg. by Natco Pharma Ltd. Kothur 509 228 A. P. India for Ranbaxy Pharmaceuticals, Jacksonville FL 33257 Lot # 404048

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

Lot# NW25310001

Exp Date: 07/2015

Dosage: see package insert.  Store at 68 to 77 degrees F.  Keep out of reach of children.

INACTIVE INGREDIENT

INGREDIENTS AND APPEARANCE

ONDANSETRON HCL 
ondansetron hcl tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51655-400(NDC:63304-458)
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)	ONDANSETRON	4 mg  in 3

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	NO;4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51655-400-43	3 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077851	03/17/2014

Labeler - Northwind Pharmaceuticals (036986393)

Registrant - Northwind Pharmaceuticals (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
Northwind Pharmceuticals		036986393	repack(51655-400)