Prescription drug · ANDA
Torsemide NDC 65862-128
Torsemide 100 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-128-01 | 65862012801 | 100 TABLET in 1 BOTTLE (65862-128-01)Marketed from Oct 17, 2007 | |
| 65862-128-99 | 65862012899 | 1000 TABLET in 1 BOTTLE (65862-128-99)Marketed from Oct 17, 2007 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078249
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 65862-128_e1cdbb1e-4104-41ee-86af-84fc73d761baSPL ID e1cdbb1e-4104-41ee-86af-84fc73d761baSPL set ID 55e88727-864e-4313-860c-31a6ca45168fRxCUI 198369, 198370, 198371, 198372UNII W31X2H97FBUPC 0365862125019, 0365862126016
- 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
N465862012801followed by a unit qualifier and the quantityPackage 65862-0128-01. 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 tablets are indicated for the treatment of edema associated with heart failure, renal disease or hepatic disease. 1.2 Hypertension Torsemide tablets are 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 in…
Excerpt only. Read the full label for complete information.
About NDC 65862-128
- What is NDC 65862-128?
- 65862-128 is the product NDC for Torsemide, Torsemide 100 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Torsemide.
- What is the active ingredient?
- Torsemide.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Torsemide?
- 60 other product NDCs are listed under this name. See all Torsemide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Torsemide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Torsemide | Torsemide 10 mg/1 | TabletOral | XLCare Pharmaceuticals Inc. | 72865-259 | 72865-0259-0172865-0259-90 |
| Torsemide | Torsemide 5 mg/1 | TabletOral | XLCare Pharmaceuticals Inc. | 72865-258 | 72865-0258-90 |
| Torsemide | Torsemide 20 mg/1 | TabletOral | XLCare Pharmaceuticals Inc. | 72865-260 | 72865-0260-0172865-0260-0572865-0260-90 |
| Torsemide | Torsemide 100 mg/1 | TabletOral | XLCare Pharmaceuticals Inc. | 72865-261 | 72865-0261-0172865-0261-90 |
| Torsemide | Torsemide 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4139 | 70518-4139-00 |
| Torsemide | Torsemide 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2412 | 72162-2412-0172162-2412-0572162-2412-09 |
| Torsemide | Torsemide 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2841 | 71335-2841-01 |
| Torsemide | Torsemide 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2663 | 71335-2663-0171335-2663-02 |
| Torsemide | Torsemide 5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-871 | 23155-0871-0123155-0871-0523155-0871-10 |
| Torsemide | Torsemide 10 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-872 | 23155-0872-0123155-0872-0523155-0872-10 |
Other NDCs under ANDA 078249
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 | Aurobindo Pharma Limited | 65862-127 |
| Torsemide | Torsemide 5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-125 |
| Torsemide | Torsemide 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-126 |
| Torsemide | Torsemide 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2143 |
| Torsemide | Torsemide 20 mg/1 | TabletOral | Redpharm Drug | 67296-2190 |
| Torsemide | Torsemide 5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-138 |
| Torsemide | Torsemide 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-139 |
| Torsemide | Torsemide 20 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-140 |
| Torsemide | Torsemide 100 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-141 |