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.
Product ID | 61919-565_75b0c827-08e6-e445-e053-2991aa0a2141 |
NDC | 61919-565 |
Product Type | Human Prescription Drug |
Proprietary Name | ONDANSETRON |
Generic Name | Ondansetron |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2016-03-23 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA078539 |
Labeler Name | DIRECT RX |
Substance Name | ONDANSETRON HYDROCHLORIDE |
Active Ingredient Strength | 4 mg/1 |
Pharm Classes | Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2019-12-31 |
Marketing Start Date | 2019-09-06 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA078539 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-09-06 |
Marketing Category | ANDA |
Application Number | ANDA078539 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2016-03-23 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA078539 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2018-09-12 |
Inactivation Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA078539 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-08-22 |
Marketing Category | ANDA |
Application Number | ANDA078539 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-08-22 |
Ingredient | Strength |
---|---|
ONDANSETRON HYDROCHLORIDE | 4 mg/1 |
SPL SET ID: | 2ebdb67e-d584-0f7b-e054-00144ff8d46c |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
0143-2422 | Ondansetron | Ondansetron hydrochloride |
0143-2423 | Ondansetron | Ondansetron hydrochloride |
0143-2424 | Ondansetron | Ondansetron |
0143-9890 | Ondansetron | Ondansetron |
0143-9891 | Ondansetron | Ondansetron |
0179-0099 | ondansetron | ondansetron hydrochloride |
0179-0100 | ondansetron | ondansetron hydrochloride |
0378-0315 | Ondansetron | ondansetron |
0378-0344 | Ondansetron | ondansetron |
0378-0374 | Ondansetron | ondansetron |
0378-7732 | Ondansetron | Ondansetron |
0378-7734 | Ondansetron | Ondansetron |
0404-9930 | ONDANSETRON | ONDANSETRON |
0409-1120 | Ondansetron | ONDANSETRON |
0409-4755 | Ondansetron | ONDANSETRON |
0409-4759 | Ondansetron | ONDANSETRON |
0641-6078 | Ondansetron | Ondansetron |
0641-6079 | Ondansetron | Ondansetron |
0641-6080 | Ondansetron | Ondansetron |
67877-169 | ondansetron | ondansetron |
67877-170 | ondansetron | ondansetron |
68001-247 | Ondansetron | Ondansetron |
68001-246 | Ondansetron | Ondansetron |
68071-1547 | Ondansetron | Ondansetron |
68071-1804 | Ondansetron | Ondansetron |
68071-1658 | Ondansetron | Ondansetron |
68071-1730 | Ondansetron | Ondansetron |
68071-1904 | Ondansetron | Ondansetron |
68071-1649 | Ondansetron | Ondansetron |
68071-1987 | Ondansetron | Ondansetron |
68071-1968 | ONDANSETRON | ONDANSETRON |
68071-1977 | ONDANSETRON | ONDANSETRON |
68071-3028 | Ondansetron | Ondansetron |
68071-3195 | Ondansetron | Ondansetron |
68071-3268 | Ondansetron | Ondansetron |
68071-4190 | Ondansetron | Ondansetron |
68071-3275 | Ondansetron | Ondansetron |
68071-4191 | ONDANSETRON | ONDANSETRON |
68071-4513 | Ondansetron | Ondansetron |
68071-4426 | Ondansetron | Ondansetron |
68071-4115 | Ondansetron | Ondansetron |
68071-4566 | Ondansetron | Ondansetron |
68071-4570 | Ondansetron | Ondansetron |
68071-4409 | Ondansetron | Ondansetron |
68071-4594 | Ondansetron | Ondansetron |
68071-4810 | Ondansetron | Ondansetron |
68071-4717 | Ondansetron | Ondansetron |
68083-114 | Ondansetron | Ondansetron |
68083-113 | Ondansetron | Ondansetron |
68071-4529 | ondansetron | ondansetron |