Prescription drug · ANDA
Amlodipine and valsartan NDC 65862-738
Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-738-03 | 65862073803 | 3 BLISTER PACK in 1 CARTON (65862-738-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-738-10)Marketed from Apr 22, 2016 | |
| 65862-738-30 | 65862073830 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-738-30)Marketed from Apr 22, 2016 | |
| 65862-738-90 | 65862073890 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-738-90)Marketed from Apr 22, 2016 |
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 and valsartan
- Generic name (nonproprietary)
- amlodipine and valsartan
- Active ingredients
- Amlodipine besylate — 5 mg/1Valsartan — 320 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206512
- 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 65862-738_909d72a6-7116-407e-8ec8-77b9b5798237SPL ID 909d72a6-7116-407e-8ec8-77b9b5798237SPL set ID 7fa25f10-29e0-4162-81a8-9d2e03054dedRxCUI 722126, 722131, 722134, 722137UNII 864V2Q084H, 80M03YXJ7IUPC 0365862739308, 0365862737304
- 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.
- NDC on a medical claim
N465862073803followed by a unit qualifier and the quantityPackage 65862-0738-03. 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 and valsartan tablets are the combination 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 press…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206512
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 320 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-740 |
| Amlodipine and valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-737 |
| Amlodipine and valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-739 |