Prescription drug · ANDA
Losartan Potassium NDC 63187-808
Losartan potassium 100 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-808-30 | 6318708083063187080830 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-808-30)Marketed from Feb 1, 2017 | |
| 63187-808-90 | 6318708089063187080890 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-808-90)Marketed from Feb 1, 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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- 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 63187-808_d019731d-bf15-4833-9676-6ff4be9b42e3SPL ID d019731d-bf15-4833-9676-6ff4be9b42e3SPL set ID 4b298291-4251-4af8-a436-58a3443a7978RxCUI 979480UNII 3ST302B24AUPC 0363187808907
- 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
N463187080830followed by a unit qualifier and the quantityPackage 63187-0808-30. 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.
About NDC 63187-808
- What is NDC 63187-808?
- 63187-808 is the product NDC for Losartan Potassium, Losartan potassium 100 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 2 package NDCs, 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?
- Proficient Rx LP, NDC labeler code 63187. 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 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 | DIRECT RX | 72189-100 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-052 |