Ondansetron by Central Packaging / Central Packaging, LLC ONDANSETRON tablet

Ondansetron by

Drug Labeling and Warnings

Ondansetron by is a Prescription medication manufactured, distributed, or labeled by Central Packaging, Central Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE FORMS & STRENGTHS

Ondansetron Tablets USP, are available in the following strengths:4 mg – white, oval, film-coated tablets engraved with "4" on one side and “NO”on other side.8 mg – yellow, oval, film-coated tablets engraved with "8" on one side and "NO" on the other side.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONDANSETRON 
ondansetron tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80175-0017(NDC:71930-017)
Route of Administration	ORAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80175-0017-5	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2018
2	NDC: 80175-0017-1	10 in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2018
3	NDC: 80175-0017-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077851	07/11/2018

Labeler - Central Packaging (117617671)

Establishment
Name	Address	ID/FEI	Business Operations
Central Packaging, LLC		117617671	repack(80175-0017)