LOTRONEX is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Prometheus Laboratories Inc.. The primary component is Alosetron Hydrochloride.
Product ID | 65483-895_800b0802-c4e6-409f-adbc-a985d1fca2a5 |
NDC | 65483-895 |
Product Type | Human Prescription Drug |
Proprietary Name | LOTRONEX |
Generic Name | Alosetron Hydrochloride |
Dosage Form | Tablet |
Route of Administration | ORAL |
Marketing Start Date | 2009-02-09 |
Marketing Category | NDA / NDA |
Application Number | NDA021107 |
Labeler Name | Prometheus Laboratories Inc. |
Substance Name | ALOSETRON HYDROCHLORIDE |
Active Ingredient Strength | 1 mg/1 |
Pharm Classes | Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] |
NDC Exclude Flag | E |
Listing Certified Through | 2017-12-31 |
Marketing Start Date | 2009-02-09 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA021107 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2009-02-09 |
Inactivation Date | 2020-01-31 |
Ingredient | Strength |
---|---|
ALOSETRON HYDROCHLORIDE | 1 mg/1 |
SPL SET ID: | 526ba44c-a476-4675-a63c-4d0a72b723f5 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
54766-894 | LOTRONEX | alosetron hydrochloride |
54766-895 | LOTRONEX | alosetron hydrochloride |
65483-894 | LOTRONEX | alosetron hydrochloride |
65483-895 | LOTRONEX | alosetron hydrochloride |
0054-0295 | Alosetron Hydrochloride | alosetron hydrochloride |
0054-0296 | Alosetron Hydrochloride | alosetron hydrochloride |
42291-123 | Alosetron Hydrochloride | Alosetron Hydrochloride |
42291-124 | Alosetron Hydrochloride | Alosetron Hydrochloride |
45963-479 | Alosetron Hydrochloride | alosetron hydrochloride |
45963-480 | Alosetron Hydrochloride | alosetron hydrochloride |
49884-819 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE |
49884-820 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE |
64980-453 | alosetron hydrochloride | alosetron hydrochloride |
64980-454 | alosetron hydrochloride | alosetron hydrochloride |
65162-248 | Alosetron Hydrochloride | Alosetron Hydrochloride |
65162-249 | Alosetron Hydrochloride | Alosetron Hydrochloride |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LOTRONEX 75294530 2238126 Live/Registered |
SEBELA IRELAND LIMITED 1997-05-19 |