Prescription drug · ANDA
Losartan Potassium NDC 63187-830
Losartan potassium 50 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-830-30 | 63187083030 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-830-30)Marketed from Apr 3, 2017 | |
| 63187-830-60 | 63187083060 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-830-60)Marketed from Apr 3, 2017 | |
| 63187-830-90 | 63187083090 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-830-90)Marketed from Apr 3, 2017 |
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, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 63187-830_2385274a-12e4-415b-b2fe-d7c7040d00aaSPL ID 2385274a-12e4-415b-b2fe-d7c7040d00aaSPL set ID c0319153-3e35-4a84-aa63-935b1e0047d8RxCUI 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
N463187083030followed by a unit qualifier and the quantityPackage 63187-0830-30. 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)
INDICATIONS AND USAGE Hypertension Losartan potassium tablets USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Hypertensive Patients with Left Ventricular Hypertrophy Losartan potassium tablets USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS, Race and Error! Hyperlink reference not valid. Nephropathy in Type 2 Diabetic Patients Losartan potassium tablets USP are indicated for the treatment of diabetic nephropathy with an elevated serum creati…
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 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2083 |
| 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 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 |