BETAPACE AF is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Covis Pharma Us, Inc. The primary component is Sotalol Hydrochloride.
Product ID | 70515-115_1b3fb38e-5546-4a55-866f-d2e2ffadaed8 |
NDC | 70515-115 |
Product Type | Human Prescription Drug |
Proprietary Name | BETAPACE AF |
Generic Name | Sotalol Hydrochloride |
Dosage Form | Tablet |
Route of Administration | ORAL |
Marketing Start Date | 2016-09-01 |
Marketing Category | NDA / NDA |
Application Number | NDA021151 |
Labeler Name | Covis Pharma US, Inc |
Substance Name | SOTALOL HYDROCHLORIDE |
Active Ingredient Strength | 80 mg/1 |
Pharm Classes | Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2016-09-01 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA021151 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2016-09-01 |
Ingredient | Strength |
---|---|
SOTALOL HYDROCHLORIDE | 80 mg/1 |
SPL SET ID: | afce2787-8899-4098-87c8-f1e8dd19e6dd |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
70515-115 | BETAPACE AF | BETAPACE AF |
70515-116 | BETAPACE AF | BETAPACE AF |
70515-119 | BETAPACE AF | BETAPACE AF |
13672-054 | Betapace AF | Betapace AF |
13672-055 | Betapace AF | Betapace AF |
13672-056 | Betapace AF | Betapace AF |
0245-0012 | Sorine | Sotalol Hydrochloride |
0245-0013 | Sorine | Sotalol Hydrochloride |
0245-0014 | Sorine | Sotalol Hydrochloride |
0245-0015 | Sorine | Sotalol Hydrochloride |
10135-661 | Sotalol | Sotalol Hydrochloride |
10135-662 | Sotalol | Sotalol Hydrochloride |
10135-663 | Sotalol | 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BETAPACE AF 75817196 2711659 Live/Registered |
COVIS PHARMA B.V. 1999-10-06 |