Prescription drug · ANDA
Losartan Potassium NDC 29300-145
Losartan potassium 50 mg/1 · Tablet · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-145-01 | 29300014501 | 100 TABLET in 1 BOTTLE, PLASTIC (29300-145-01)Marketed from Feb 28, 2018 | |
| 29300-145-10 | 29300014510 | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-145-10)Marketed from Feb 28, 2018 | |
| 29300-145-13 | 29300014513 | 30 TABLET in 1 BOTTLE, PLASTIC (29300-145-13)Marketed from Feb 28, 2018 | |
| 29300-145-19 | 29300014519 | 90 TABLET in 1 BOTTLE, PLASTIC (29300-145-19)Marketed from Feb 28, 2018 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203030
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 29300-145_cedb47f7-7b7e-464f-b1ed-2a3afdb074d4SPL ID cedb47f7-7b7e-464f-b1ed-2a3afdb074d4SPL set ID 92691768-b5e6-4527-98dc-d86c58f6f13eRxCUI 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
N429300014501followed by a unit qualifier and the quantityPackage 29300-0145-01. 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 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 ar…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203030
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 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-144 |
| Losartan Potassium | Losartan potassium 100 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-146 |
| Losartan Potassium | Losartan potassium 25 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2506 |
| Losartan Potassium | Losartan potassium 50 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2507 |
| Losartan Potassium | Losartan potassium 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2508 |