Prescription drug · ANDA
Losartan Potassium and Hydrochlorothiazide NDC 68180-215
Hydrochlorothiazide 12.5 mg/1; Losartan potassium 50 mg/1 · Tablet · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-215-06 | 68180021506 | 30 TABLET in 1 BOTTLE (68180-215-06)Marketed from Oct 6, 2010 | |
| 68180-215-09 | 68180021509 | 90 TABLET in 1 BOTTLE (68180-215-09)Marketed from Oct 6, 2010 |
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 and Hydrochlorothiazide
- Generic name (nonproprietary)
- losartan potassium and hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide — 12.5 mg/1Losartan potassium — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- 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 68180-215_84f3649d-3ced-4765-ba22-d0fbaeffa820SPL ID 84f3649d-3ced-4765-ba22-d0fbaeffa820SPL set ID ee1eaaf6-050b-48af-942b-5e3451edc164RxCUI 979464, 979468, 979471UNII 3ST302B24A, 0J48LPH2THUPC 0368180215066, 0368180217060
- 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
N468180021506followed by a unit qualifier and the quantityPackage 68180-0215-06. 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 | Bryant Ranch Prepack | 71335-2558 |
| 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 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 |