Prescription drug · ANDA
Losartan Potassium and Hydrochlorothiazide NDC 71335-2558
Hydrochlorothiazide 25 mg/1; Losartan potassium 100 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2558-1 | 71335255801 | 30 TABLET in 1 BOTTLE (71335-2558-1)Marketed from Jan 23, 2025 | |
| 71335-2558-2 | 71335255802 | 90 TABLET in 1 BOTTLE (71335-2558-2)Marketed from Jan 23, 2025 | |
| 71335-2558-3 | 71335255803 | 60 TABLET in 1 BOTTLE (71335-2558-3)Marketed from Jan 23, 2025 |
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 and Hydrochlorothiazide
- Generic name (nonproprietary)
- losartan potassium and hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide — 25 mg/1Losartan potassium — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078245
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 71335-2558_db6c4965-367c-4960-a33d-4975be838cfaSPL ID db6c4965-367c-4960-a33d-4975be838cfaSPL set ID b4f5dd93-5f44-4c8c-9e3b-89ab1fa5a7fdRxCUI 979471UNII 0J48LPH2TH, 3ST302B24A
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Thiazide Diuretic
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
N471335255801followed by a unit qualifier and the quantityPackage 71335-2558-01. 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 and hydrochlorothiazide tablet is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure. 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 ) 1.1 Hypertension Losartan potassium and hydrochlorothiazide tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078245
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 and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Losartan potassium 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7664 |
| Losartan Potassium And Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Direct_Rx | 72189-167 |
| Losartan Potassium and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 100 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-216 |
| Losartan Potassium and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 50 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-215 |
| Losartan Potassium and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Losartan potassium 100 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-217 |
| Losartan Potassium and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8632 |
| Losartan Potassium and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Losartan potassium 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-4993 |