Prescription drug · ANDA
Amlodipine, Valsartan, Hydrochlorothiazide NDC 51407-672
amlodipine besylate valsartan hydrochlorothiazide · Amlodipine besylate 10 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-672-30 | 51407067230 | 30 TABLET, FILM COATED in 1 BOTTLE (51407-672-30)Marketed from Aug 1, 2022 |
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)
- Amlodipine, Valsartan, Hydrochlorothiazide
- Generic name (nonproprietary)
- amlodipine besylate valsartan hydrochlorothiazide
- Active ingredients
- Amlodipine besylate — 10 mg/1Hydrochlorothiazide — 25 mg/1Valsartan — 320 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201087
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 51407-672_369be7a6-2236-ab19-e063-6394a90a880fSPL ID 369be7a6-2236-ab19-e063-6394a90a880fSPL set ID e9ecbadb-c548-6fe5-e053-2a95a90a7577RxCUI 848131, 848135, 848140, 848145, 848151UNII 864V2Q084H, 0J48LPH2TH, 80M03YXJ7I
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel 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
N451407067230followed by a unit qualifier and the quantityPackage 51407-0672-30. 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)
Amlodipine/valsartan/hydrochlorothiazide is 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 amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, l…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201087
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 |
|---|---|---|---|---|
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-669 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-670 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-671 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-199 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-197 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-198 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-200 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-201 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-668 |