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NDC 65862-0391-30 Ondansetron 8 mg/1 Details
Ondansetron 8 mg/1
Ondansetron is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is ONDANSETRON.
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: 65862-0391-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ondansetron
Product Information
| NDC | 65862-0391 |
|---|---|
| Product ID | 65862-391_77ae0eb0-b1ce-441d-8cfa-1d3113f2d79e |
| Associated GPIs | 50250065007240 |
| GCN Sequence Number | 041563 |
| GCN Sequence Number Description | ondansetron TAB RAPDIS 8 MG ORAL |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 20046 |
| HICL Sequence Number | 019058 |
| HICL Sequence Number Description | ONDANSETRON |
| Brand/Generic | Generic |
| Proprietary Name | Ondansetron |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ondansetron |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, ORALLY DISINTEGRATING |
| Route | ORAL |
| Active Ingredient Strength | 8 |
| Active Ingredient Units | mg/1 |
| Substance Name | ONDANSETRON |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090469 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0391-30 (65862039130)
| NDC Package Code | 65862-391-30 |
|---|---|
| Billing NDC | 65862039130 |
| Package | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-30) |
| Marketing Start Date | 2010-04-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |