Prescription drug · ANDA
Losartan Potassium And Hydrochlorothiazide NDC 72189-167
Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-167-30 | 72189016730 | 30 TABLET in 1 BOTTLE (72189-167-30)Marketed from Jan 8, 2021 | |
| 72189-167-90 | 72189016790 | 90 TABLET in 1 BOTTLE (72189-167-90)Marketed from Jan 8, 2021 |
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
- Losartan potassium — 100 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_Rx
- 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 72189-167_2becfaea-c7d6-ec34-e063-6294a90af5b3SPL ID 2becfaea-c7d6-ec34-e063-6294a90af5b3SPL set ID 8de04bf2-83dd-c494-e053-2a95a90abadeRxCUI 979464, 979468, 979471UNII 3ST302B24A, 0J48LPH2TH
- 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
N472189016730followed by a unit qualifier and the quantityPackage 72189-0167-30. 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)
1.1 Hypertension Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 and hydrochlorothiazide. 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 patients will…
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 | 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 |