Sotalol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Sotalol Hydrochloride.
| Product ID | 10135-662_43615ac7-ce53-4272-a0b7-32b614c19eb6 |
| NDC | 10135-662 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Sotalol |
| Generic Name | Sotalol Hydrochloride |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-10-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207428 |
| Labeler Name | Marlex Pharmaceuticals Inc |
| Substance Name | SOTALOL HYDROCHLORIDE |
| Active Ingredient Strength | 120 mg/1 |
| Pharm Classes | Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207428 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-10-01 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-20 |
| Ingredient | Strength |
|---|---|
| SOTALOL HYDROCHLORIDE | 120 mg/1 |
| SPL SET ID: | 3c24cdf0-4648-4e5d-993c-1f428ce56a65 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 10135-661 | Sotalol | Sotalol Hydrochloride |
| 10135-662 | Sotalol | Sotalol Hydrochloride |
| 10135-663 | Sotalol | Sotalol Hydrochloride |
| 76385-116 | Sotalol | Sotalol |
| 76385-114 | Sotalol | Sotalol |
| 76385-115 | Sotalol | Sotalol |
| 71335-1189 | Sotalol | Sotalol |
| 71610-385 | Sotalol | Sotalol |
| 0245-0012 | Sorine | Sotalol Hydrochloride |
| 0245-0013 | Sorine | Sotalol Hydrochloride |
| 0245-0014 | Sorine | Sotalol Hydrochloride |
| 0245-0015 | Sorine | Sotalol Hydrochloride |
| 0093-1060 | Sotalol Hydrochloride | Sotalol Hydrochloride |
| 0093-1061 | Sotalol Hydrochloride | Sotalol Hydrochloride |
| 0093-1062 | Sotalol Hydrochloride | Sotalol Hydrochloride |
| 0093-1063 | Sotalol Hydrochloride | Sotalol Hydrochloride |
| 0185-0170 | sotalol hydrochloride | sotalol hydrochloride |
| 0185-0171 | sotalol hydrochloride | sotalol hydrochloride |
| 0185-0174 | sotalol hydrochloride | sotalol hydrochloride |
| 0185-0177 | sotalol hydrochloride | sotalol hydrochloride |
| 0378-5123 | Sotalol Hydrochloride | sotalol hydrochloride |
| 0378-5124 | Sotalol Hydrochloride | sotalol hydrochloride |
| 0378-5125 | Sotalol Hydrochloride | sotalol hydrochloride |
| 0603-5769 | Sotalol Hydrochloride | Sotalol Hydrochloride |
| 0603-5770 | Sotalol Hydrochloride | Sotalol Hydrochloride |
| 0603-5771 | Sotalol Hydrochloride | Sotalol Hydrochloride |
| 0603-5772 | Sotalol Hydrochloride | Sotalol Hydrochloride |
| 0615-5552 | Sotalol Hydrochloride | Sotalol Hydrochloride |
| 0615-7888 | Sotalol Hydrochloride | Sotalol Hydrochloride |
| 0904-7143 | Sotalol Hydrochloride | Sotalol Hydrochloride |