Prescription drug · ANDA
Losartan Potassium NDC 46708-445
Losartan potassium 25 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-445-30 | 46708044530 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-445-30)Marketed from May 23, 2016 | |
| 46708-445-31 | 46708044531 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-445-31)Marketed from May 23, 2016 | |
| 46708-445-90 | 46708044590 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-445-90)Marketed from May 23, 2016 | |
| 46708-445-91 | 46708044591 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-445-91)Marketed from May 23, 2016 |
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)
- Losartan Potassium
- Generic name (nonproprietary)
- losartan potassium
- Active ingredients
- Losartan potassium — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090428
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 46708-445_cedeb352-a540-4778-84e6-304f898fe17fSPL ID cedeb352-a540-4778-84e6-304f898fe17fSPL set ID eeb77c84-38d3-432d-914a-54b312b374bdRxCUI 979480, 979485, 979492UNII 3ST302B24AUPC 0346708447304, 0346708445300, 0346708446307
- 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
N446708044530followed by a unit qualifier and the quantityPackage 46708-0445-30. 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 tablet USP is 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 potassium table…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090428
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 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-027 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-028 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-029 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-446 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-447 |