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NDC 70515-0109-10 BETAPACE 120 mg/1 Details
BETAPACE 120 mg/1
BETAPACE 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.
MedlinePlus Drug Summary
Sotalol is used to treat irregular heartbeats. Sotalol is in a class of medications called antiarrhythmics. It works by acting on the heart muscle to improve the heart's rhythm.
Related Packages: 70515-0109-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sotalol
Product Information
| NDC | 70515-0109 |
|---|---|
| Product ID | 70515-109_2e894da6-0d45-4db6-b0d2-8667c989d155 |
| Associated GPIs | 33100045100315 |
| GCN Sequence Number | 024097 |
| GCN Sequence Number Description | sotalol HCl TABLET 120 MG ORAL |
| HIC3 | J7C |
| HIC3 Description | BETA-ADRENERGIC BLOCKING AGENTS |
| GCN | 39516 |
| HICL Sequence Number | 004791 |
| HICL Sequence Number Description | SOTALOL HCL |
| Brand/Generic | Brand |
| Proprietary Name | BETAPACE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sotalol hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 120 |
| Active Ingredient Units | mg/1 |
| Substance Name | SOTALOL HYDROCHLORIDE |
| Labeler Name | Covis Pharma US, Inc |
| Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA019865 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70515-0109-10 (70515010910)
| NDC Package Code | 70515-109-10 |
|---|---|
| Billing NDC | 70515010910 |
| Package | 100 TABLET in 1 BOTTLE (70515-109-10) |
| Marketing Start Date | 2016-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |