Prescription drug · ANDA
Losartan Potassium NDC 68180-307
Losartan potassium 25 mg/1 · Tablet · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Losartan Potassium
- Generic name (nonproprietary)
- losartan potassium
- Active ingredients
- Losartan potassium — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- 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 68180-307_38431fb6-7157-4be5-929a-0c65b7a29c55SPL ID 38431fb6-7157-4be5-929a-0c65b7a29c55SPL set ID e5886220-43b7-46e1-9034-5242ba245bd1RxCUI 979480, 979485, 979492UNII 3ST302B24AUPC 0368180212065, 0368180376033, 0368180210061, 0368180378037, 0368180308027, 0368180376095, 0368180211068, 0368180309024, 0368180377030
- 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Losartan potassium tablet 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 tablets a…
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 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-3403 |
| 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 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 |