Prescription drug · ANDA
Losartan Potassium NDC 50090-3403
Losartan potassium 100 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3403-0 | 50090340300 | 90 TABLET in 1 BOTTLE (50090-3403-0)Marketed from Mar 15, 2018 | |
| 50090-3403-1 | 50090340301 | 30 TABLET in 1 BOTTLE, PLASTIC (50090-3403-1)Marketed from Nov 1, 2017 | |
| 50090-3403-2 | 50090340302 | 100 TABLET in 1 BOTTLE (50090-3403-2)Marketed from Mar 9, 2023 |
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
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078232
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-3403_908adc3a-3c4d-4905-906a-386b2eb708aaSPL ID 908adc3a-3c4d-4905-906a-386b2eb708aaSPL set ID 679be0b9-bb60-4970-ad50-0041a6d67bf8RxCUI 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
N450090340300followed by a unit qualifier and the quantityPackage 50090-3403-00. 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 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 078232
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 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-5480 |
| Losartan Potassium | Losartan potassium 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3282 |
| Losartan Potassium | Losartan potassium 25 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-210 |
| Losartan Potassium | Losartan potassium 50 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-211 |
| Losartan Potassium | Losartan potassium 100 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-212 |
| Losartan Potassium | Losartan potassium 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-5626 |
| Losartan Potassium | Losartan potassium 25 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-307 |
| Losartan Potassium | Losartan potassium 50 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-308 |
| Losartan Potassium | Losartan potassium 100 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-309 |
| Losartan Potassium | Losartan potassium 25 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-376 |
| Losartan Potassium | Losartan potassium 50 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-377 |
| Losartan Potassium | Losartan potassium 100 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-378 |