Prescription drug · ANDA
Valsartan And Hydrochlorothiazide NDC 68788-8463
Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8463-3 | 68788846303 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8463-3)Marketed from Jun 23, 2023 | |
| 68788-8463-6 | 68788846306 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8463-6)Marketed from Jun 23, 2023 | |
| 68788-8463-9 | 68788846309 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8463-9)Marketed from Jun 23, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 160 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 206083
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 68788-8463_0324b913-3ee4-4e08-94db-ef5201e4581aSPL ID 0324b913-3ee4-4e08-94db-ef5201e4581aSPL set ID d09747f0-029e-4090-949b-e939948249b5RxCUI 200285UNII 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
N468788846303followed by a unit qualifier and the quantityPackage 68788-8463-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 206083
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 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2618 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2617 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2633 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7443 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7442 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7444 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2200 |
| Valsartan And Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-311 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-315 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-312 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-313 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-314 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6232 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3070 |