Prescription drug · ANDA
Amlodipine, Valsartan and Hydrochlorothiazide NDC 68180-774
Amlodipine besylate 10 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Amlodipine, Valsartan and Hydrochlorothiazide
- Generic name (nonproprietary)
- amlodipine, valsartan and hydrochlorothiazide
- Active ingredients
- Amlodipine besylate — 10 mg/1Valsartan — 160 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200797
- 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 68180-774_5e938b33-b86d-40ab-b5c5-b7137ef9404dSPL ID 5e938b33-b86d-40ab-b5c5-b7137ef9404dSPL set ID 5dbb43b1-3ea4-4fa5-a9aa-95d869ae65feRxCUI 848131, 848135, 848140, 848145, 848151UNII 0J48LPH2TH, 864V2Q084H, 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Amlodipine, 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 amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, i…
Excerpt only. Read the full label for complete information.
About NDC 68180-774
- What is NDC 68180-774?
- 68180-774 is the product NDC for Amlodipine, Valsartan and Hydrochlorothiazide, Amlodipine besylate 10 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Amlodipine, Valsartan and Hydrochlorothiazide.
- What is the active ingredient?
- Amlodipine besylate, Valsartan, Hydrochlorothiazide.
- 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, Valsartan and Hydrochlorothiazide?
- 14 other product NDCs are listed under this name. See all Amlodipine, Valsartan and Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amlodipine, Valsartan and Hydrochlorothiazide 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,valsartan and hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-283 | 33342-0283-0733342-0283-1033342-0283-12 |
| amlodipine,valsartan and hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-284 | 33342-0284-0733342-0284-1033342-0284-12 |
| amlodipine,valsartan and hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-285 | 33342-0285-0733342-0285-1033342-0285-12 |
| amlodipine,valsartan and hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-286 | 33342-0286-0733342-0286-1033342-0286-12 |
| amlodipine,valsartan and hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-287 | 33342-0287-0733342-0287-1033342-0287-12 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-834 | 65862-0834-0565862-0834-3065862-0834-90 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-835 | 65862-0835-0565862-0835-3065862-0835-90 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-836 | 65862-0836-0565862-0836-3065862-0836-90 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-837 | 65862-0837-0565862-0837-3065862-0837-90 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-838 | 65862-0838-0565862-0838-3065862-0838-90 |
Other NDCs under ANDA 200797
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 and Hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-773 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-771 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-772 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-775 |