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NDC 53002-0601-03 Ondansetron Hydrochloride 8 mg/1 Details
Ondansetron Hydrochloride 8 mg/1
Ondansetron Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. 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: 53002-0601-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ondansetron
Product Information
| NDC | 53002-0601 |
|---|---|
| Product ID | 53002-0601_db2cc2fc-e398-4627-bb58-802ab322334b |
| 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 Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ondansetron Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 8 |
| Active Ingredient Units | mg/1 |
| Substance Name | ONDANSETRON HYDROCHLORIDE |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078539 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-0601-03 (53002060103)
| NDC Package Code | 53002-0601-3 |
|---|---|
| Billing NDC | 53002060103 |
| Package | 10 TABLET, FILM COATED in 1 BOTTLE (53002-0601-3) |
| Marketing Start Date | 2019-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |