Prescription drug · ANDA
Amlodipine Besylate NDC 0615-8654
Amlodipine besylate 5 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8654-05 | 00615865405 | 15 TABLET in 1 BLISTER PACK (0615-8654-05)Marketed from Jul 28, 2026 | |
| 0615-8654-07 | 00615865407 | 7 TABLET in 1 BLISTER PACK (0615-8654-07)Marketed from Jul 28, 2026 | |
| 0615-8654-28 | 00615865428 | 28 TABLET in 1 BLISTER PACK (0615-8654-28)Marketed from Aug 19, 2026 | |
| 0615-8654-30 | 00615865430 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8654-30) / 5 TABLET in 1 BLISTER PACKMarketed from Jul 31, 2026 | |
| 0615-8654-39 | 00615865439 | 30 TABLET in 1 BLISTER PACK (0615-8654-39)Marketed from Jul 28, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 078925
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 0615-8654_fb199085-040a-4002-9c0b-11396f13cf0aSPL ID fb199085-040a-4002-9c0b-11396f13cf0aSPL set ID 6efc0ef6-0424-44fc-a9ea-eb30c3b83239RxCUI 197361, 308135, 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
N400615865405followed by a unit qualifier and the quantityPackage 00615-8654-05. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | 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 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7955 |
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