Amlodipine Besylate NDC 43489-100

NDC codes

FDA NDC Directory

Product NDC (as listed)43489-100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43489-0100Add 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
43489-100-01	43489010001	90 TABLET in 1 BOTTLE, PLASTIC (43489-100-01)Marketed from May 23, 2016
43489-100-03	43489010003	500 TABLET in 1 BOTTLE, PLASTIC (43489-100-03)Marketed from May 23, 2016
43489-100-05	43489010005	1000 TABLET in 1 BOTTLE, PLASTIC (43489-100-05)Marketed from May 23, 2016

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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: China Resources Saike Pharmaceutical Co., Ltd.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090752
Marketing start: Apr 15, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 43489-100_53c969a7-d151-97a6-e063-6394a90ae408SPL ID 53c969a7-d151-97a6-e063-6394a90ae408SPL set ID 3518853a-4c5b-4161-a178-8da7f656f009RxCUI 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

N443489010001 followed by a unit qualifier and the quantity

Package 43489-0100-01. 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 Jun 8, 2026.

Indications (excerpt from the label)

Amlodipine is 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 is 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 is indicated for the treatment of hypertension, to lower bloo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090752

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

FDA NDC Directory listings under ANDA 090752
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	China Resources Saike Pharmaceutical Co., Ltd.	43489-101
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	China Resources Saike Pharmaceutical Co., Ltd.	43489-102