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NDC 61919-0565-12 ONDANSETRON 4 mg/1 Details
ONDANSETRON 4 mg/1
ONDANSETRON is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Direct_Rx. 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: 61919-0565-12Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ondansetron
Product Information
| NDC | 61919-0565 |
|---|---|
| Product ID | 61919-565_f9ddfe4f-20ce-fcf5-e053-6394a90aa680 |
| Associated GPIs | 50250065050310 |
| GCN Sequence Number | 016392 |
| GCN Sequence Number Description | ondansetron HCl TABLET 4 MG ORAL |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 20041 |
| 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 | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | mg/1 |
| Substance Name | ONDANSETRON HYDROCHLORIDE |
| Labeler Name | Direct_Rx |
| 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 61919-0565-12 (61919056512)
| NDC Package Code | 61919-565-12 |
|---|---|
| Billing NDC | 61919056512 |
| Package | 12 TABLET, FILM COATED in 1 BOTTLE (61919-565-12) |
| Marketing Start Date | 2019-09-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |