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NDC 72789-0135-01 Sotalol Hydrochloride 160 mg/1 Details
Sotalol Hydrochloride 160 mg/1
Sotalol Hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, 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: 72789-0135-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sotalol
Product Information
| NDC | 72789-0135 |
|---|---|
| Product ID | 72789-135_0632abb2-518b-7c34-e063-6394a90a2318 |
| Associated GPIs | 33100045100320 |
| 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 | Generic |
| Proprietary Name | Sotalol Hydrochloride |
| 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 | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075563 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72789-0135-01 (72789013501)
| NDC Package Code | 72789-135-01 |
|---|---|
| Billing NDC | 72789013501 |
| Package | 100 TABLET in 1 BOTTLE, PLASTIC (72789-135-01) |
| Marketing Start Date | 2020-11-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |