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NDC 70515-0116-06 BETAPACE AF 160 mg/1 Details
BETAPACE AF 160 mg/1
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.
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: 70515-0116-06Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sotalol
Product Information
| NDC | 70515-0116 |
|---|---|
| Product ID | 70515-116_2e894da6-0d45-4db6-b0d2-8667c989d155 |
| Associated GPIs | 33100045120320 |
| GCN Sequence Number | 013497 |
| GCN Sequence Number Description | sotalol HCl TABLET 160 MG ORAL |
| HIC3 | J7C |
| HIC3 Description | BETA-ADRENERGIC BLOCKING AGENTS |
| GCN | 39511 |
| HICL Sequence Number | 004791 |
| HICL Sequence Number Description | SOTALOL HCL |
| Brand/Generic | Brand |
| Proprietary Name | BETAPACE AF |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sotalol hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 160 |
| 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 | NDA021151 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70515-0116-06 (70515011606)
| NDC Package Code | 70515-116-06 |
|---|---|
| Billing NDC | 70515011606 |
| Package | 60 TABLET in 1 BOTTLE (70515-116-06) |
| Marketing Start Date | 2016-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |