Prescription drug · ANDA
Losartan potassium and Hydrochlorothiazide NDC 33342-051
Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-051-07 | 33342005107 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-051-07)Marketed from Sep 10, 2012 | |
| 33342-051-10 | 33342005110 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-051-10)Marketed from Sep 10, 2012 | |
| 33342-051-12 | 33342005112 | 10 BLISTER PACK in 1 CARTON (33342-051-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 10, 2012 | |
| 33342-051-44 | 33342005144 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-051-44)Marketed from Sep 10, 2012 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202289
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 33342-051_cf31d31e-9355-47da-9c2b-8e4b84ac8159SPL ID cf31d31e-9355-47da-9c2b-8e4b84ac8159SPL set ID a04b5622-2c49-4d61-92b1-5dc523af7a24RxCUI 979464, 979468, 979471UNII 3ST302B24A, 0J48LPH2THUPC 0333342051448, 0333342050106, 0333342052100, 0333342051103, 0333342052445, 0333342051073, 0333342052070
- 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
N433342005107followed by a unit qualifier and the quantityPackage 33342-0051-07. 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 tablets are 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 tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202289
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 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2492 |
| Losartan Potassium And Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-290 |
| Losartan Potassium And Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-289 |
| Losartan Potassium And Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 50 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-297 |
| Losartan potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3048 |
| Losartan potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-050 |
| Losartan potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-052 |