Prescription drug · ANDA
Torsemide NDC 43353-315
Torsemide 20 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-315-16 | 43353031516 | 6000 TABLET in 1 BOTTLE, PLASTIC (43353-315-16)Marketed from May 3, 2017 |
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)
- Torsemide
- Generic name (nonproprietary)
- torsemide
- Active ingredients
- Torsemide — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076943
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 43353-315_cd00a5cc-04b6-49cd-89d0-ae552b415f5dSPL ID cd00a5cc-04b6-49cd-89d0-ae552b415f5dSPL set ID b869bc45-1ebb-42fb-82c5-603f09835790RxCUI 198371UNII W31X2H97FB
- Pharmacologic class
- Loop Diuretic
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
N443353031516followed by a unit qualifier and the quantityPackage 43353-0315-16. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Torsemide is a loop diuretic indicated for: • the treatment of edema associated with heart failure, renal disease or hepatic disease. ( 1.1 ) • the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.2 ) 1.1 Edema Torsemide is indicated for the treatment of edema associated with heart failure, renal disease, or hepatic disease. 1.2 Hypertension Torsemide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076943
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 |
|---|---|---|---|---|
| Torsemide | Torsemide 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0077 |
| Torsemide | Torsemide 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2195 |
| Torsemide | Torsemide 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-819 |
| Torsemide | Torsemide 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-362 |