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NDC 76045-0216-20 ONDANSETRON 4 mg/2mL Details

ONDANSETRON 4 mg/2mL

ONDANSETRON is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is ONDANSETRON HYDROCHLORIDE.

MedlinePlus Drug Summary

Ondansetron injection is used to prevent nausea and vomiting caused by cancer chemotherapy 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: 76045-0216-20
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ondansetron Injection

Product Information

NDC	76045-0216
Product ID	76045-216_b71a45e3-2b90-4199-b88b-fef27cb394fc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ONDANSETRON
Proprietary Name Suffix	n/a
Non-Proprietary Name	ONDANSETRON HYDROCHLORIDE
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	INJECTION, SOLUTION
Route	INTRAMUSCULAR; INTRAVENOUS
Active Ingredient Strength	4
Active Ingredient Units	mg/2mL
Substance Name	ONDANSETRON HYDROCHLORIDE
Labeler Name	Fresenius Kabi USA, LLC
Pharmaceutical Class	Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA202253
Listing Certified Through	2024-12-31

Package

NDC 76045-0216-20 (76045021620)

Pricing Information	N/A
NDC Package Code	76045-216-20
Billing NDC	76045021620
Package	24 BLISTER PACK in 1 CARTON (76045-216-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-216-00) / 2 mL in 1 SYRINGE, GLASS
Marketing Start Date	2022-05-31
NDC Exclude Flag	N