Zofran is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Advanced Rx Pharmacy Of Tennessee, Llc. The primary component is Ondansetron Hydrochloride.
| Product ID | 80425-0075_b22feddb-eba6-1d1a-e053-2a95a90ab389 |
| NDC | 80425-0075 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Zofran |
| Generic Name | Ondansetron Hcl 8mg |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2007-07-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA078539 |
| Labeler Name | Advanced Rx Pharmacy of Tennessee, LLC |
| Substance Name | ONDANSETRON HYDROCHLORIDE |
| Active Ingredient Strength | 8 mg/1 |
| Pharm Classes | Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2007-07-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0078-0675 | ZOFRAN | ondansetron hydrochloride |
| 0078-0676 | ZOFRAN | ondansetron hydrochloride |
| 0078-0679 | ZOFRAN | ondansetron hydrochloride |
| 0078-0680 | ZOFRAN | ondansetron hydrochloride |
| 0173-0447 | ZOFRAN | ondansetron hydrochloride |
| 0173-0489 | ZOFRAN | ondansetron hydrochloride |
| 80425-0072 | Zofran | Ondansetron 4mg |
| 80425-0073 | Zofran | Ondansetron OD 4mg |
| 80425-0075 | Zofran | Ondansetron HCl 8mg |
| 80425-0113 | Zofran | Ondansetron 4mg |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZOFRAN 73670524 1592702 Live/Registered |
GLAXO GROUP LIMITED 1987-07-06 |