Prescription drug · ANDA
Losartan Potassium NDC 71335-2083
Losartan potassium 100 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2083-1 | 71335208301 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2083-1)Marketed from Apr 14, 2023 | |
| 71335-2083-2 | 71335208302 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2083-2)Marketed from Apr 14, 2023 | |
| 71335-2083-3 | 71335208303 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2083-3)Marketed from Apr 14, 2023 | |
| 71335-2083-4 | 71335208304 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2083-4)Marketed from Apr 14, 2023 | |
| 71335-2083-5 | 71335208305 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2083-5)Marketed from Apr 14, 2023 | |
| 71335-2083-6 | 71335208306 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2083-6)Marketed from Apr 14, 2023 | |
| 71335-2083-7 | 71335208307 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2083-7)Marketed from Apr 14, 2023 | |
| 71335-2083-8 | 71335208308 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2083-8)Marketed from Apr 14, 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, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091497
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-2083_99e2c90f-c40d-47cd-aa57-b0d0aca07bdaSPL ID 99e2c90f-c40d-47cd-aa57-b0d0aca07bdaSPL set ID de987691-f659-45ab-9c53-402ef7421f4bRxCUI 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
N471335208301followed by a unit qualifier and the quantityPackage 71335-2083-01. 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 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 ar…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091497
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 | NuCare Pharmaceuticals.Inc. | 68071-3846 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-100 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-052 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8186 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4007 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8189 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-808 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-207 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-224 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-830 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3489 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-226 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1088 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-361 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-360 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-362 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,iNc. | 68071-1517 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2690 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0262 |