Prescription drug · ANDA
Amlodipine Besylate NDC 71610-539
Amlodipine besylate 5 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-539-60 | 71610053960 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-539-60)Marketed from Apr 7, 2021 |
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 203245
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 71610-539_882a3c50-8604-4230-aeb5-9b9df2f02a15SPL ID 882a3c50-8604-4230-aeb5-9b9df2f02a15SPL set ID afcffa7b-03b7-499a-b50c-37b0e28c7737RxCUI 197361UNII 864V2Q084H
- Pharmacologic class
- 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
N471610053960followed by a unit qualifier and the quantityPackage 71610-0539-60. 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 calcium channel blockers and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension ( 1.1 ) 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 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate tablets are indi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203245
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 5 mg/1 | TabletOral | Proficient Rx LP | 71205-599 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2359 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-399 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4464 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8543 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1865 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6809 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6808 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-031 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2305 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Direct_Rx | 72189-520 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Direct_Rx | 72189-529 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6876 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6877 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-398 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-396 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-397 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Proficient Rx LP | 71205-506 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Quality Care Products, LLC | 83008-035 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-445 |
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