Prescription drug · ANDA
LOSARTAN POTASSIUM 50 mg (losartan potassium) NDC 64380-934
Losartan potassium 50 mg/1 · Tablet, Film coated · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-934-04 | 64380093404 | 30 TABLET, FILM COATED in 1 BOTTLE (64380-934-04)Marketed from Oct 9, 2019 | |
| 64380-934-05 | 64380093405 | 90 TABLET, FILM COATED in 1 BOTTLE (64380-934-05)Marketed from Oct 9, 2019 | |
| 64380-934-08 | 64380093408 | 1000 TABLET, FILM COATED in 1 BOTTLE (64380-934-08)Marketed from Oct 9, 2019 |
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 50 mgSuffix: 50 mg
- Generic name (nonproprietary)
- losartan potassium
- Active ingredients
- Losartan potassium — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090382
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 64380-934_de8fc110-fa21-4904-8309-fd3c28dfff44SPL ID de8fc110-fa21-4904-8309-fd3c28dfff44SPL set ID a8817f22-8478-49b9-8354-ab27ca222c6bRxCUI 979480, 979485, 979492UNII 3ST302B24AUPC 0364380933052, 0364380935056, 0364380935087, 0364380935049, 0364380934042, 0364380933045, 0364380934080, 0364380933083, 0364380934059
- 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
N464380093404followed by a unit qualifier and the quantityPackage 64380-0934-04. 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 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 potassium tablets are i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090382
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 50 mglosartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-418 |
| LOSARTAN POTASSIUM 50 mglosartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-598 |
| LOSARTAN POTASSIUM 25 mglosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-282 |
| LOSARTAN POTASSIUM 100 mglosartan potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2203 |
| LOSARTAN POTASSIUM 25 mglosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-675 |
| LOSARTAN POTASSIUM 25 mglosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-933 |
| LOSARTAN POTASSIUM 100 mglosartan potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-935 |
| LOSARTAN POTASSIUM 50 mglosartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-164 |
| LOSARTAN POTASSIUM 25 mglosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-163 |
| LOSARTAN POTASSIUM 100 mglosartan potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-165 |
| LOSARTAN POTASSIUM 50 mglosartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-179 |