Prescription drug · ANDA
Amlodipine and Valsartan NDC 68180-766
Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 · Tablet · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Amlodipine and Valsartan
- Generic name (nonproprietary)
- amlodipine and valsartan
- Active ingredients
- Amlodipine besylate — 5 mg/1Valsartan — 320 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090245
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 68180-766_e0777a79-35ef-4f69-b6ac-94d31f7ca6fbSPL ID e0777a79-35ef-4f69-b6ac-94d31f7ca6fbSPL set ID 35086164-bf92-4b3c-9845-f8cd7464c7d6RxCUI 722126, 722131, 722134, 722137UNII 864V2Q084H, 80M03YXJ7IUPC 0368180765110, 0368180766117, 0368180767114, 0368180764113
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker
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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Amlodipine and valsartan tablet is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled on monotherapy ( 1 ) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ( 1 ). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090245
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 and Valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-765 |
| Amlodipine and Valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-764 |
| Amlodipine and Valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-767 |