Prescription drug · ANDA
Losartan Potassium and Hydrochlorothiazide NDC 63187-347
Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-347-30 | 63187034730 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-347-30)Marketed from Aug 21, 2023 | |
| 63187-347-60 | 63187034760 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-347-60)Marketed from Aug 21, 2023 | |
| 63187-347-90 | 63187034790 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-347-90)Marketed from Aug 21, 2023 |
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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 63187-347_6bff4e15-4418-45b5-8c30-2ff825249f9cSPL ID 6bff4e15-4418-45b5-8c30-2ff825249f9cSPL set ID 8d992a4c-8740-4636-928f-bb808eae3336RxCUI 979471UNII 3ST302B24A, 0J48LPH2THUPC 0363187347307
- 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
N463187034730followed by a unit qualifier and the quantityPackage 63187-0347-30. 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)
INDICATIONS AND USAGE Hypertension Losartan potassium and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY , Pharmacodynamics and Clinical Effects , and DOSAGE AND ADMINISTRATION ). Hypertensive Patients With Left Ventricular Hypertrophy Losartan potassium and hydrochlorothiazide tablets USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular…
Excerpt only. Read the full label for complete information.
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 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-552 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7367 |
| 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 | Direct_Rx | 72189-098 |
| 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 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 |