What is NDC 72189-162?

72189-162 is the product NDC for Amlodipine Besylate, Amlodipine besylate 2.5 mg/1 tablet, listed with the FDA by DIRECT RX. It has 1 package NDC, shown above in 10- and 11-digit form.

DIRECT RX, NDC labeler code 72189. 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 72189-162 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-162Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0162Add 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
72189-162-90	7218901629072189016290	90 TABLET in 1 BOTTLE (72189-162-90)Marketed from Jan 12, 2021

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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: DIRECT RXNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078925
Marketing start: Jan 12, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 72189-162_2be94c25-4a48-39f0-e063-6294a90ab40cSPL ID 2be94c25-4a48-39f0-e063-6294a90ab40cSPL set ID b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719RxCUI 308136, 898342UNII N1SN99T69T, 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

N472189016290 followed by a unit qualifier and the quantity

Package 72189-0162-90. 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 Jan 17, 2025.

Indications (excerpt from the label)

1.1 Hypertension 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including Amlodipine besylate tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to ac…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-162

What is NDC 72189-162?: 72189-162 is the product NDC for Amlodipine Besylate, Amlodipine besylate 2.5 mg/1 tablet, listed with the FDA by DIRECT RX. It has 1 package NDC, 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?: DIRECT RX, NDC labeler code 72189. 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	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8654
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

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