ONDANSETRON- ondansetron tablet, film coated 
DIRECT RX

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ONDANSETRON 4mg

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

ONDANESTRON 4 mg

10

ONDANSETRON 
ondansetron tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-565(NDC:65862-187)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS) ONDANSETRON4 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (WHITE TO OFF WHITE) Scoreno score
ShapeOVALSize6mm
FlavorImprint Code F;91
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-565-2020 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2016
2NDC:61919-565-101 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07853903/23/2016
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-565)

Revised: 9/2018
Document Id: 75b0c827-08e6-e445-e053-2991aa0a2141
Set id: 2ebdb67e-d584-0f7b-e054-00144ff8d46c
Version: 2
Effective Time: 20180912
 
DIRECT RX