Prescription drug · ANDA
Losartan Potassium NDC 71335-1235
Losartan potassium 100 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1235-1 | 71335123501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1235-1)Marketed from May 30, 2019 | |
| 71335-1235-2 | 71335123502 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1235-2)Marketed from Jul 9, 2024 | |
| 71335-1235-3 | 71335123503 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1235-3)Marketed from Jun 21, 2019 | |
| 71335-1235-4 | 71335123504 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1235-4)Marketed from Jul 9, 2024 | |
| 71335-1235-5 | 71335123505 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1235-5)Marketed from Jul 9, 2024 | |
| 71335-1235-6 | 71335123506 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1235-6)Marketed from Jul 9, 2024 | |
| 71335-1235-7 | 71335123507 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1235-7)Marketed from Sep 3, 2019 | |
| 71335-1235-8 | 71335123508 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1235-8)Marketed from Jul 9, 2024 |
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 090083
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-1235_2e19e89b-daac-449a-a511-217ed561f5fdSPL ID 2e19e89b-daac-449a-a511-217ed561f5fdSPL set ID 4d7a0e82-4791-4e3f-932a-2f1a2993ba36RxCUI 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
N471335123501followed by a unit qualifier and the quantityPackage 71335-1235-01. 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 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090083
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 | NuCare Pharmaceuticals,Inc. | 68071-5041 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-281 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5040 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-918 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-125 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0245 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6714 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-203 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-201 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-202 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0718 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2132 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-083 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-053 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-954 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2316 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-955 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1174 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1221 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-791 |
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