Prescription drug · ANDA
Amlodipine, Valsartan and Hydrochlorothiazide NDC 65862-837
Amlodipine besylate 10 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-837-05 | 6586208370565862083705 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-837-05)Marketed from Dec 19, 2017 | |
| 65862-837-30 | 6586208373065862083730 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-837-30)Marketed from Dec 19, 2017 | |
| 65862-837-90 | 6586208379065862083790 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-837-90)Marketed from Dec 19, 2017 |
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 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
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206180
- 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 65862-837_a583a371-730c-4f0a-86b6-01e654770f16SPL ID a583a371-730c-4f0a-86b6-01e654770f16SPL set ID 6fba5243-ee00-4825-a04a-321cb6b49c56RxCUI 848131, 848135, 848140, 848145, 848151UNII 80M03YXJ7I, 0J48LPH2TH, 864V2Q084HUPC 0365862836304, 0365862835307, 0365862837301, 0365862834300
- 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
N465862083705followed by a unit qualifier and the quantityPackage 65862-0837-05. 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 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 65862-837
- What is NDC 65862-837?
- 65862-837 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 Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amlodipine, Valsartan and Hydrochlorothiazide.
- What is the active ingredient?
- Amlodipine besylate, Valsartan, Hydrochlorothiazide.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 | 65862-838 | 65862-0838-0565862-0838-3065862-0838-90 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-771 | — |
Other NDCs under ANDA 206180
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 | Aurobindo Pharma Limited | 65862-834 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-835 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-836 |
| Amlodipine, Valsartan and Hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-838 |