Prescription drug · ANDA
Amlodipine Besylate NDC 71610-691
Amlodipine besylate 5 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-691-15 | 71610069115 | 15 TABLET in 1 BOTTLE (71610-691-15)Marketed from Mar 7, 2023 | |
| 71610-691-30 | 71610069130 | 30 TABLET in 1 BOTTLE (71610-691-30)Marketed from Mar 7, 2023 | |
| 71610-691-45 | 71610069145 | 45 TABLET in 1 BOTTLE (71610-691-45)Marketed from Mar 7, 2023 | |
| 71610-691-60 | 71610069160 | 90 TABLET in 1 BOTTLE (71610-691-60)Marketed from May 4, 2023 |
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 Besylate
- Generic name (nonproprietary)
- amlodipine besylate
- Active ingredients
- Amlodipine besylate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078552
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 71610-691_9417d815-3b9a-4f80-93bc-3452217d5fe9SPL ID 9417d815-3b9a-4f80-93bc-3452217d5fe9SPL set ID 186b6149-9610-4380-9bf2-941646069276RxCUI 197361UNII 864V2Q084H
- Pharmacologic class
- 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
N471610069115followed by a unit qualifier and the quantityPackage 71610-0691-15. 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 .
Indications (excerpt from the label)
Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension ( 1.1 ) o Amlodipine besylate 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. • Coronary Artery Disease ( 1.2 ) o Chronic Stable Angina o Vasospastic Angina (Prinzmetal’s or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%. 1.1 Hypertension Amlodipine Besylate Ta…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078552
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 Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-580 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-620 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Epic Pharma, LLC | 42806-056 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Epic Pharma, LLC | 42806-055 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Epic Pharma, LLC | 42806-057 |