Prescription drug · ANDA
Losortan Potassium (losartan potassium) NDC 50268-506
Losartan potassium 100 mg/1 · Tablet, Film coated · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-506-15 | 50268050615 | 50 BLISTER PACK in 1 BOX (50268-506-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-506-11)Marketed from May 29, 2020 |
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)
- Losortan Potassium
- Generic name (nonproprietary)
- losartan potassium
- Active ingredients
- Losartan potassium — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078243
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50268-506_47e73292-3507-3131-e063-6294a90a0de6SPL ID 47e73292-3507-3131-e063-6294a90a0de6SPL set ID a6cd0b5f-2bd6-bed9-e053-2995a90a3191RxCUI 979480, 979485, 979492UNII 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
N450268050615followed by a unit qualifier and the quantityPackage 50268-0506-15. 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078243
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 | Quallent Pharmaceuticals Health LLC | 82009-044 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-082 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-042 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-043 |
| Losortan Potassiumlosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-504 |
| Losortan Potassiumlosartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-505 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-730 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-729 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-731 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-347 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-346 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-348 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7959 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7960 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4783 |
| Losortan Potassiumlosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8639 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7958 |
| Losortan Potassiumlosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1644 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2089 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-135 |
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