NDC codes

FDA NDC Directory
Product NDC (as listed)67046-0328Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-0328Add 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 NDC11-digit (billing)PackageCopy
67046-0328-3670460328036704603280330 TABLET in 1 BLISTER PACK (67046-0328-3)Marketed from Dec 11, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Coupler LLCNDC labeler code 67046
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078925
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 67046-0328_51b3fe7c-d6e0-f7f3-e063-6394a90ac9c2SPL ID 51b3fe7c-d6e0-f7f3-e063-6394a90ac9c2SPL set ID 2904c6e1-2c51-8035-e063-6294a90aa04bRxCUI 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

N467046032803 followed by a unit qualifier and the quantity

Package 67046-0328-03. 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 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 tablets is in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-0328

What is NDC 67046-0328?
67046-0328 is the product NDC for Amlodipine Besylate, Amlodipine besylate 2.5 mg/1 tablet, listed with the FDA by Coupler LLC. 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?
Coupler LLC, NDC labeler code 67046. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralAmerican Health Packaging60687-96160687-0961-01
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralAmerican Health Packaging60687-97260687-0972-01
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralDirect_Rx72189-68972189-0689-90
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralCoupler LLC67046-115767046-1157-03
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralUnit Dose Solutions, Inc.87441-01687441-0016-01
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralUnit Dose Solutions, Inc.87441-01787441-0017-01
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralSafecor Health LLC48433-15548433-0155-20
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralSafecor Health LLC48433-15648433-0156-20
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralSafecor Health LLC48433-15748433-0157-20
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralREMEDYREPACK INC.70518-462970518-4629-0070518-4629-02

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
ProductStrengthForm · routeLabelerProduct NDC
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8430
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8431
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8647
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8652
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8654
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralQPharma Inc42708-066
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralQPharma, Inc.42708-204
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-041
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-564
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralA-S Medication Solutions50090-1627
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralA-S Medication Solutions50090-2524
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralA-S Medication Solutions50090-2581
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralA-S Medication Solutions50090-5059
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralA-S Medication Solutions50090-5550
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralA-S Medication Solutions50090-6853
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralA-S Medication Solutions50090-7955
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralA-S Medication Solutions50090-7956
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralNorthwind Health Company, LLC51655-291
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralNorthwind Health Company, LLC51655-586
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralQuality Care Products, LLC55700-543

Showing 20 of 39.

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