Prescription drug · ANDA
Sotalol Hydrochloride NDC 60505-0082
Sotalol hydrochloride 240 mg/1 · Tablet · Oral · Apotex Corp.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)60505-0082Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-0082Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0082-0 | 60505008200 | 100 TABLET in 1 BOTTLE (60505-0082-0)Marketed from Feb 1, 2003 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 240 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076140
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
- Identifiers
- Product ID 60505-0082_56c7802b-7509-33d1-228e-44b9d9a6e2e4SPL ID 56c7802b-7509-33d1-228e-44b9d9a6e2e4
- 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
N460505008200followed by a unit qualifier and the quantityPackage 60505-0082-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-0082
- What is NDC 60505-0082?
- 60505-0082 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 240 mg/1 tablet, listed with the FDA by Apotex Corp.. It has 1 package NDC, 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?
- Apotex Corp., NDC labeler code 60505. 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 076140
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 | Major Pharmaceuticals | 0904-7143 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | A-S Medication Solutions | 50090-1299 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | AvPAK | 50268-724 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | AvPAK | 50268-725 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-450 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-8179 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-748 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Apotex Corp. | 60505-0080 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Apotex Corp. | 60505-0081 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Apotex Corp. | 60505-0159 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Proficient Rx LP | 63187-804 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | American Health Packaging | 68084-654 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0260 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1125 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-723 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-849 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2118 |