Prescription drug · ANDA
Valsartan and Hydrochlorothiazide NDC 63187-943
Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-943-30 | 63187094330 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-943-30)Marketed from Jan 1, 2018 | |
| 63187-943-60 | 63187094360 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-943-60)Marketed from Jan 1, 2018 | |
| 63187-943-90 | 63187094390 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-943-90)Marketed from Jan 1, 2018 |
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)
- Valsartan and Hydrochlorothiazide
- Generic name (nonproprietary)
- valsartan and hydrochlorothiazide
- Active ingredients
- Valsartan — 80 mg/1Hydrochlorothiazide — 12.5 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 201662
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 63187-943_2d51bede-441e-4d75-ab5f-22736967d958SPL ID 2d51bede-441e-4d75-ab5f-22736967d958SPL set ID a06ee3c1-bd0d-4dda-a453-1655eebffdaeRxCUI 200284UNII 80M03YXJ7I, 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
N463187094330followed by a unit qualifier and the quantityPackage 63187-0943-30. 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)
Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid contr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201662
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 |
|---|---|---|---|---|
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-015 |
| Valsartan and Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3292 |
| Valsartan and Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4872 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-042 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0853 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-456 |
| Valsartan and Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-453 |
| Valsartan and Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-454 |
| Valsartan and Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-455 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-457 |
| Valsartan and Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-079 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-083 |
| Valsartan and Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-080 |
| Valsartan and Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-081 |
| Valsartan and Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-082 |