Prescription drug · ANDA
Amlodipine Besylate NDC 65841-620
Amlodipine besylate 2.5 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-620-01 | 65841062001 | 100 TABLET in 1 BOTTLE (65841-620-01)Marketed from Sep 21, 2007 | |
| 65841-620-05 | 65841062005 | 500 TABLET in 1 BOTTLE (65841-620-05)Marketed from Sep 21, 2007 | |
| 65841-620-16 | 65841062016 | 90 TABLET in 1 BOTTLE (65841-620-16)Marketed from Sep 21, 2007 | |
| 65841-620-77 | 65841062077 | 10 BLISTER PACK in 1 CARTON (65841-620-77) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 21, 2007 |
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
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078226
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 65841-620_cb1a9e7c-aa86-4596-bc0d-86d8b5750963SPL ID cb1a9e7c-aa86-4596-bc0d-86d8b5750963SPL set ID cacb3551-c579-41cb-bed6-4b4d8b0644fcRxCUI 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
N465841062001followed by a unit qualifier and the quantityPackage 65841-0620-01. 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 .
Other NDCs under ANDA 078226
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 2.5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-8093 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6369 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6370 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6371 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-122 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-121 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-123 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-6875 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-6892 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-621 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-622 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Safecor Health LLC | 48433-156 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Safecor Health LLC | 48433-155 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Safecor Health LLC | 48433-157 |