Prescription drug · ANDA
Losartan Potassium And Hydrochlorothiazide NDC 72189-098
Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-098-90 | 7218900989072189009890 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-098-90)Marketed from Jun 12, 2020 |
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, Film coated
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077157
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 72189-098_2becfaea-c7d6-ec34-e063-6294a90af5b3SPL ID 2becfaea-c7d6-ec34-e063-6294a90af5b3SPL set ID 8de04bf2-83dd-c494-e053-2a95a90abadeRxCUI 979464, 979468, 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
N472189009890followed by a unit qualifier and the quantityPackage 72189-0098-90. 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.
About NDC 72189-098
- What is NDC 72189-098?
- 72189-098 is the product NDC for Losartan Potassium And Hydrochlorothiazide, Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Losartan Potassium And Hydrochlorothiazide.
- What is the active ingredient?
- Losartan potassium, Hydrochlorothiazide.
- Who is the labeler?
- Direct_Rx, NDC labeler code 72189. 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 And Hydrochlorothiazide?
- 107 other product NDCs are listed under this name. See all Losartan Potassium And Hydrochlorothiazide 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 And Hydrochlorothiazide 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 And Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-755 | 31722-0755-1031722-0755-3031722-0755-90 |
| Losartan Potassium And Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-756 | 31722-0756-1031722-0756-3031722-0756-90 |
| Losartan Potassium And Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-757 | 31722-0757-1031722-0757-3031722-0757-90 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1618 | 67046-1618-03 |
| Losartan potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2492 | 72162-2492-0072162-2492-09 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7821 | 50090-7821-00 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4447 | 50090-4447-0050090-4447-0150090-4447-02 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-224 | 16714-0224-0116714-0224-0216714-0224-03 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-225 | 16714-0225-0116714-0225-0216714-0225-04 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-226 | 16714-0226-0116714-0226-0216714-0226-04 |
Other NDCs under ANDA 077157
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 | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7368 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7369 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-552 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4518 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | QPharma Inc | 42708-036 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-347 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7367 |