What is NDC 0615-8654?

0615-8654 is the product NDC for Amlodipine Besylate, Amlodipine besylate 5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 5 package NDCs, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amlodipine Besylate?

167 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amlodipine Besylate NDC 0615-8654 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8654Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8654Add 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
0615-8654-05	0061586540500615865405	15 TABLET in 1 BLISTER PACK (0615-8654-05)Marketed from Jul 28, 2026
0615-8654-07	0061586540700615865407	7 TABLET in 1 BLISTER PACK (0615-8654-07)Marketed from Jul 28, 2026
0615-8654-28	0061586542800615865428	28 TABLET in 1 BLISTER PACK (0615-8654-28)Marketed from Aug 19, 2026
0615-8654-30	0061586543000615865430	6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8654-30) / 5 TABLET in 1 BLISTER PACKMarketed from Jul 31, 2026
0615-8654-39	0061586543900615865439	30 TABLET in 1 BLISTER PACK (0615-8654-39)Marketed from Jul 28, 2026

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: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078925
Marketing start: Dec 6, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 0615-8654_fb199085-040a-4002-9c0b-11396f13cf0aSPL ID fb199085-040a-4002-9c0b-11396f13cf0aSPL set ID 6efc0ef6-0424-44fc-a9ea-eb30c3b83239RxCUI 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

N400615865405 followed by a unit qualifier and the quantity

Package 00615-8654-05. 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 Sep 1, 2026.

Indications (excerpt from the label)

Amlodipine besylate tablets 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 besylate tablets 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 besylate table…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8654

What is NDC 0615-8654?: 0615-8654 is the product NDC for Amlodipine Besylate, Amlodipine besylate 5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amlodipine Besylate.
What is the active ingredient?: Amlodipine besylate.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amlodipine Besylate?: 167 other product NDCs are listed under this name. See all Amlodipine Besylate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Amlodipine Besylate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	American Health Packaging	60687-961	60687-0961-01
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	American Health Packaging	60687-972	60687-0972-01
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Direct_Rx	72189-689	72189-0689-90
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Coupler LLC	67046-1157	67046-1157-03
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-016	87441-0016-01
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-017	87441-0017-01
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Safecor Health LLC	48433-155	48433-0155-20
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Safecor Health LLC	48433-156	48433-0156-20
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Safecor Health LLC	48433-157	48433-0157-20
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4629	70518-4629-0070518-4629-02

All 168 Amlodipine Besylate NDCs

Other NDCs under ANDA 078925

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

FDA NDC Directory listings under ANDA 078925
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8430
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8431
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8647
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8652
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	QPharma Inc	42708-066
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	QPharma, Inc.	42708-204
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-041
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-564
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	A-S Medication Solutions	50090-1627
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	A-S Medication Solutions	50090-2524
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	A-S Medication Solutions	50090-2581
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	A-S Medication Solutions	50090-5059
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	A-S Medication Solutions	50090-5550
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	A-S Medication Solutions	50090-6853
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	A-S Medication Solutions	50090-7955
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	A-S Medication Solutions	50090-7956
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Northwind Health Company, LLC	51655-291
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Northwind Health Company, LLC	51655-586
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Quality Care Products, LLC	55700-543
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	American Health Packaging	60687-488

Showing 20 of 39.