Prescription drug · ANDA
Amlodipine Besylate NDC 72189-529
Amlodipine besylate 10 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-529-30 | 72189052930 | 30 TABLET in 1 BOTTLE (72189-529-30)Marketed from Dec 14, 2023 | |
| 72189-529-90 | 72189052990 | 90 TABLET in 1 BOTTLE (72189-529-90)Marketed from Dec 14, 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_Rx
- 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)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 72189-529_39ab6651-a795-ad78-e063-6294a90a8a8dSPL ID 39ab6651-a795-ad78-e063-6294a90a8a8dSPL set ID 0c7d1f99-dfe0-7041-e063-6294a90a9705RxCUI 308135UNII 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
N472189052930followed by a unit qualifier and the quantityPackage 72189-0529-30. 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)
1.1 Hypertension 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to a…
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 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-539 |
| 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 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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