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NDC 76045-0103-20 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: 76045-0103-20Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ondansetron Injection
Product Information
| NDC | 76045-0103 |
|---|---|
| Product ID | 76045-103_b71a45e3-2b90-4199-b88b-fef27cb394fc |
| Associated GPIs | 5025006505E520 |
| GCN Sequence Number | 062183 |
| GCN Sequence Number Description | ondansetron HCl/PF SYRINGE 4 MG/2 ML INJECTION |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 97968 |
| HICL Sequence Number | 033598 |
| HICL Sequence Number Description | ONDANSETRON HCL/PF |
| Brand/Generic | Generic |
| 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 76045-0103-20 (76045010320)
| NDC Package Code | 76045-103-20 |
|---|---|
| Billing NDC | 76045010320 |
| Package | 24 BLISTER PACK in 1 CARTON (76045-103-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-103-00) / 2 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2015-12-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |