Amlodipine Besylate NDC 68645-580

NDC codes

FDA NDC Directory

Product NDC (as listed)68645-580Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68645-0580Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68645-580-54	68645058054	30 TABLET in 1 BOTTLE (68645-580-54)Marketed from Apr 25, 2011

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: Legacy Pharmaceutical Packaging, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078552
Marketing start: Apr 25, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 68645-580_4c219dee-9f8c-6c56-e063-6294a90accf8SPL ID 4c219dee-9f8c-6c56-e063-6294a90accf8SPL set ID 215ef2cb-d5b6-43d5-bbd5-195ec57cde2bRxCUI 308135UNII 864V2Q084HUPC 0368645580548
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

N468645058054 followed by a unit qualifier and the quantity

Package 68645-0580-54. 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 Mar 3, 2026.

Indications (excerpt from the label)

Amlodipine besylate tablets are 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 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 ) 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 are in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078552

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078552
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-620
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Epic Pharma, LLC	42806-056
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Epic Pharma, LLC	42806-055
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Epic Pharma, LLC	42806-057
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-691