Prescription drug · ANDA
Amlodipine Besylate NDC 67046-0328
Amlodipine besylate 2.5 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-0328-3 | 67046032803 | 30 TABLET in 1 BLISTER PACK (67046-0328-3)Marketed from Dec 11, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Coupler LLC
- 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 67046-0328_51b3fe7c-d6e0-f7f3-e063-6394a90ac9c2SPL ID 51b3fe7c-d6e0-f7f3-e063-6394a90ac9c2SPL set ID 2904c6e1-2c51-8035-e063-6294a90aa04bRxCUI 308136UNII 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
N467046032803followed by a unit qualifier and the quantityPackage 67046-0328-03. 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 .
Indications (excerpt from the label)
Amlodipine besylate tablets is 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 ) 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. • 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 is in…
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 | Bryant Ranch Prepack | 71335-3126 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7955 |
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