Prescription drug · ANDA
Losartan potassium NDC 70518-4289
Losartan potassium 100 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4289-0 | 70518428900 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4289-0)Marketed from Feb 14, 2025 |
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)
- Losartan potassium
- Generic name (nonproprietary)
- losartan potassium
- Active ingredients
- Losartan potassium — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202230
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70518-4289_5a9625fa-0c62-f50f-e063-6394a90a5b82SPL ID 5a9625fa-0c62-f50f-e063-6394a90a5b82SPL set ID a397502e-abe7-49cf-97c7-d53a616947ebRxCUI 979480UNII 3ST302B24A
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
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
N470518428900followed by a unit qualifier and the quantityPackage 70518-4289-00. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3 ) 1.1 Hypertension Losartan potass…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202230
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 |
|---|---|---|---|---|
| Losartan potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-046 |
| Losartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-044 |
| Losartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-045 |
| Losartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1510 |
| Losartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4127 |