Prescription drug · ANDA
Losartan Potassium and Hydrochlorothiazide NDC 46708-450
Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-450-10 | 4670804501046708045010 | 100 BLISTER PACK in 1 CARTON (46708-450-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 23, 2016 | |
| 46708-450-30 | 4670804503046708045030 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-450-30)Marketed from May 23, 2016 | |
| 46708-450-90 | 4670804509046708045090 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-450-90)Marketed from May 23, 2016 | |
| 46708-450-91 | 4670804509146708045091 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-450-91)Marketed from May 23, 2016 |
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
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091617
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 46708-450_d80ae5dd-3bdc-40a4-9589-dfb7f8eabe6dSPL ID d80ae5dd-3bdc-40a4-9589-dfb7f8eabe6dSPL set ID bbf7e20d-dfc2-4115-8788-c0cac15a1148RxCUI 979464, 979468, 979471UNII 0J48LPH2TH, 3ST302B24AUPC 0346708448301, 0346708449308, 0346708450304
- 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
N446708045010followed by a unit qualifier and the quantityPackage 46708-0450-10. 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 USP 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 USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering b…
Excerpt only. Read the full label for complete information.
About NDC 46708-450
- What is NDC 46708-450?
- 46708-450 is the product NDC for Losartan Potassium and Hydrochlorothiazide, Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 091617
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 | Alembic Pharmaceuticals Limited | 46708-449 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-448 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4159 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-049 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-048 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-050 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-918 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-394 |