Prescription drug · ANDA
Sotalol Hydrochloride NDC 82804-951
Sotalol hydrochloride 120 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC DirectoryProduct NDC (as listed)82804-951Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0951Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-951-00 | 82804095100 | 100 TABLET in 1 BOTTLE (82804-951-00)Marketed from Jan 12, 2026 | |
| 82804-951-11 | 82804095111 | 1000 TABLET in 1 BOTTLE (82804-951-11)Marketed from Jan 12, 2026 | |
| 82804-951-30 | 82804095130 | 30 TABLET in 1 BOTTLE (82804-951-30)Marketed from Jan 12, 2026 | |
| 82804-951-55 | 82804095155 | 500 TABLET in 1 BOTTLE (82804-951-55)Marketed from Jan 12, 2026 | |
| 82804-951-60 | 82804095160 | 60 TABLET in 1 BOTTLE (82804-951-60)Marketed from Jan 12, 2026 | |
| 82804-951-72 | 82804095172 | 120 TABLET in 1 BOTTLE (82804-951-72)Marketed from Jan 12, 2026 | |
| 82804-951-90 | 82804095190 | 90 TABLET in 1 BOTTLE (82804-951-90)Marketed from Jan 12, 2026 | |
| 82804-951-96 | 82804095196 | 300 TABLET in 1 BOTTLE (82804-951-96)Marketed from Jan 12, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sotalol Hydrochloride
- Generic name (nonproprietary)
- sotalol hydrochloride
- Active ingredients
- Sotalol hydrochloride — 120 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075563
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
- Identifiers
- Product ID 82804-951_10b7b81d-9ce7-4025-8559-fdfa41c8b146SPL ID 10b7b81d-9ce7-4025-8559-fdfa41c8b146SPL set ID 10b7b81d-9ce7-4025-8559-fdfa41c8b146RxCUI 1923422UNII HEC37C70XXUPC 0382804951307
- Pharmacologic class
- Antiarrhythmic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482804095100followed by a unit qualifier and the quantityPackage 82804-0951-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 82804-951
- What is NDC 82804-951?
- 82804-951 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 120 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sotalol Hydrochloride.
- What is the active ingredient?
- Sotalol hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sotalol Hydrochloride?
- 62 other product NDCs are listed under this name. See all Sotalol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sotalol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-051 | 11788-0051-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-052 | 11788-0052-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-053 | 11788-0053-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-054 | 11788-0054-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2583 | 72162-2583-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2584 | 72162-2584-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2585 | 72162-2585-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2586 | 72162-2586-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-775 | 59651-0775-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-776 | 59651-0776-01 |
Other NDCs under ANDA 075563
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | A-S Medication Solutions | 50090-7796 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2421 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2422 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2423 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-841 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-842 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-843 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-844 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1917 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2823 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-474 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1931 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1932 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1933 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-135 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-136 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-137 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-138 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Proficient Rx LP | 82804-974 |