NDC codes

FDA NDC Directory
Product NDC (as listed)42708-066Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42708-0066Add 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
42708-066-30427080066304270800663030 TABLET in 1 BOTTLE (42708-066-30)Marketed from Aug 16, 2018 · Sample package

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
QPharma IncNDC labeler code 42708
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 42708-066_45b3d5c6-5c65-777f-e063-6294a90a58a5SPL ID 45b3d5c6-5c65-777f-e063-6294a90a58a5SPL set ID 3f74ed2b-4712-4026-ac2c-9239a211dde3RxCUI 197361UNII 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

N442708006630 followed by a unit qualifier and the quantity

Package 42708-0066-30. 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 42708-066

What is NDC 42708-066?
42708-066 is the product NDC for Amlodipine Besylate, Amlodipine besylate 5 mg/1 tablet, listed with the FDA by QPharma Inc. 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?
QPharma Inc, NDC labeler code 42708. 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, 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
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralAmerican Health Packaging60687-488

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