ONDANSETRON tablet, film coated

ONDANSETRON by

Drug Labeling and Warnings

ONDANSETRON by is a Prescription medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy.
2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.

CONTRAINDICATIONS

WARNINGS

ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE AND ADMINISTRATION

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONDANSETRON 
ondansetron tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-565(NDC:65862-187)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white (WHITE TO OFF WHITE)	Score	no score
Shape	OVAL	Size	6mm
Flavor		Imprint Code	F;91
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-565-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2016
2	NDC: 61919-565-10	1 in 1 BOTTLE; Type 0: Not a Combination Product	09/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078539	03/23/2016

Labeler - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	repack(61919-565)