Prescription drug · ANDA
Amlodipine Besylate NDC 0904-6370
Amlodipine besylate 5 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6370-61 | 00904637061 | 100 BLISTER PACK in 1 CARTON (0904-6370-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 20, 2013 |
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
- Labeler
- Major Pharmaceuticals
- 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 0904-6370_77bde698-3ec9-4c6d-8e77-1bc3e950778bSPL ID 77bde698-3ec9-4c6d-8e77-1bc3e950778bSPL set ID edf9b22c-e37e-4b4e-8a64-20bb036c7d2dRxCUI 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
N400904637061followed by a unit qualifier and the quantityPackage 00904-6370-61. 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, USP 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 ) o Amlodipine besylate tablets, USP 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 ) o Chronic Stable Angina o Vasospastic Angina (Prinzmetal's or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besy…
Excerpt only. Read the full label for complete information.
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 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 2.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-620 |
| 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 |