Prescription drug · ANDA
Amlodipine Besylate NDC 82804-164
Amlodipine besylate 10 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-164-90 | 82804016490 | 90 TABLET in 1 BOTTLE (82804-164-90)Marketed from Nov 6, 2024 |
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
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078043
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 82804-164_f18148f9-42b2-43dc-9cf8-212d9121dc5fSPL ID f18148f9-42b2-43dc-9cf8-212d9121dc5fSPL set ID f18148f9-42b2-43dc-9cf8-212d9121dc5fRxCUI 308135UNII 864V2Q084HUPC 0382804164905
- 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
N482804016490followed by a unit qualifier and the quantityPackage 82804-0164-90. 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)
Amlodipine besylate tablets are calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: •Hypertension ( 1.1 ) о 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. •Coronary Artery Disease ( 1.2 ) о Chronic Stable Angina о Vasospastic Angina (Prinzmetal's or Variant Angina) о Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate tablets…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078043
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 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5354 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5355 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-721 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3698 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-233 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4085 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4082 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2507 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Coupler LLC | 67046-1157 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-455 |