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NDC 65162-0691-19 Ondansetron 4 mg/5mL Details

Ondansetron 4 mg/5mL

Ondansetron is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is ONDANSETRON HYDROCHLORIDE.

MedlinePlus Drug Summary

Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron is in a class of medications called serotonin 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.

Related Packages: 65162-0691-19
Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Ondansetron

Product Information

NDC	65162-0691
Product ID	65162-691_bf32c962-3bd9-49ed-a1d8-c8876c219939
Associated GPIs	50250065052070
GCN Sequence Number	028107
GCN Sequence Number Description	ondansetron HCl SOLUTION 4 MG/5 ML ORAL
HIC3	H6J
HIC3 Description	ANTIEMETIC/ANTIVERTIGO AGENTS
GCN	20040
HICL Sequence Number	006055
HICL Sequence Number Description	ONDANSETRON HCL
Brand/Generic	Generic
Proprietary Name	Ondansetron
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ondansetron
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	4
Active Ingredient Units	mg/5mL
Substance Name	ONDANSETRON HYDROCHLORIDE
Labeler Name	Amneal Pharmaceuticals LLC
Pharmaceutical Class	Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA091483
Listing Certified Through	2025-12-31

Package

NDC 65162-0691-19 (65162069119)

Pricing Information	N/A
NDC Package Code	65162-691-19
Billing NDC	65162069119
Package	10 CUP, UNIT-DOSE in 1 TRAY (65162-691-19) / 5 mL in 1 CUP, UNIT-DOSE (65162-691-37)
Marketing Start Date	2010-12-17
NDC Exclude Flag	N