Prescription drug · ANDA
Losartan Potassium NDC 72189-100
Losartan potassium 25 mg/1 · Tablet, Film coated · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-100-90 | 7218901009072189010090 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-100-90)Marketed from May 13, 2020 |
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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- DIRECT RXNDC labeler code 72189
- 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 72189-100_2be871d4-0d2d-9f90-e063-6294a90ad6d2SPL ID 2be871d4-0d2d-9f90-e063-6294a90ad6d2SPL set ID a58c56b2-e05c-6697-e053-2a95a90ad466RxCUI 979485UNII 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
N472189010090followed by a unit qualifier and the quantityPackage 72189-0100-90. 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)
1.1 Hypertension Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many pati…
Excerpt only. Read the full label for complete information.
About NDC 72189-100
- What is NDC 72189-100?
- 72189-100 is the product NDC for Losartan Potassium, Losartan potassium 25 mg/1 tablet, film coated, listed with the FDA by DIRECT RX. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Losartan Potassium.
- What is the active ingredient?
- Losartan potassium.
- Who is the labeler?
- DIRECT RX, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Losartan Potassium?
- 173 other product NDCs are listed under this name. See all Losartan Potassium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Losartan Potassium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Losartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-876 | 60760-0876-30 |
| Losartan potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4773 | 70518-4773-00 |
| Losartan Potassiumlosartan | Losartan potassium 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4160 | 68788-4160-0368788-4160-09 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4695 | 70518-4695-0070518-4695-01 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-052 | 87441-0052-01 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-053 | 87441-0053-01 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0702 | 67046-0702-03 |
| Losartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4127 | 68788-4127-0368788-4127-09 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1088 | 67046-1088-03 |
| Losartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4091 | 68788-4091-0368788-4091-09 |
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 25 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-360 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-361 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-362 |
| 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 | Proficient Rx LP | 63187-830 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1088 |
| 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 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals.Inc. | 68071-3846 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4007 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8186 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8189 |
| 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 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0262 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2083 |
| 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 | Unit Dose Solutions, Inc. | 87441-052 |