Prescription drug · ANDA
Amlodipine Besylate NDC 72189-162
Amlodipine besylate 2.5 mg/1 · Tablet · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-162-90 | 72189016290 | 90 TABLET in 1 BOTTLE (72189-162-90)Marketed from Jan 12, 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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- DIRECT RX
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078925
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 72189-162_2be94c25-4a48-39f0-e063-6294a90ab40cSPL ID 2be94c25-4a48-39f0-e063-6294a90ab40cSPL set ID b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719RxCUI 308136, 898342UNII 864V2Q084H, N1SN99T69T
- 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
N472189016290followed by a unit qualifier and the quantityPackage 72189-0162-90. 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 is 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 ac…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078925
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8654 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | QPharma, Inc. | 42708-204 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7985 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Proficient Rx LP | 71205-596 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | American Health Packaging | 60687-488 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1971 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2981 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8429 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | American Health Packaging | 60687-496 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0945 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8652 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8430 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-016 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8431 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-901 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-017 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-900 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-902 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Coupler LLC | 67046-0328 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3126 |
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