Prescription drug · ANDA
Amlodipine and Valsartan NDC 68180-764
Amlodipine besylate 5 mg/1; Valsartan 160 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 — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- 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 68180-764_e0777a79-35ef-4f69-b6ac-94d31f7ca6fbSPL ID e0777a79-35ef-4f69-b6ac-94d31f7ca6fbSPL set ID 35086164-bf92-4b3c-9845-f8cd7464c7d6RxCUI 722126, 722131, 722134, 722137UNII 80M03YXJ7I, 864V2Q084HUPC 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.
About NDC 68180-764
- What is NDC 68180-764?
- 68180-764 is the product NDC for Amlodipine and Valsartan, Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Amlodipine and Valsartan.
- What is the active ingredient?
- Amlodipine besylate, Valsartan.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amlodipine and Valsartan?
- 39 other product NDCs are listed under this name. See all Amlodipine and Valsartan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amlodipine and Valsartan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amlodipine And Valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Cadila Pharmaceuticals Limited | 71209-023 | 71209-0023-0171209-0023-04 |
| Amlodipine And Valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Cadila Pharmaceuticals Limited | 71209-024 | 71209-0024-0171209-0024-04 |
| Amlodipine And Valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Cadila Pharmaceuticals Limited | 71209-022 | 71209-0022-0171209-0022-04 |
| Amlodipine And Valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Cadila Pharmaceuticals Limited | 71209-021 | 71209-0021-0171209-0021-04 |
| amlodipine and valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-282 | 33342-0282-0733342-0282-1033342-0282-12 |
| amlodipine and valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-279 | 33342-0279-0733342-0279-1033342-0279-12 |
| amlodipine and valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-280 | 33342-0280-0733342-0280-1033342-0280-12 |
| amlodipine and valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-281 | 33342-0281-0733342-0281-1033342-0281-12 |
| Amlodipine and Valsartan | Amlodipine 5 mg/1; Valsartan 160 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-844 | 23155-0844-0323155-0844-09 |
| Amlodipine and Valsartan | Amlodipine 10 mg/1; Valsartan 160 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-845 | 23155-0845-0323155-0845-09 |
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 320 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-766 |
| Amlodipine and Valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-767 |