What is NDC 76282-507?

76282-507 is the product NDC for Amlodipine besylate, Amlodipine besylate 2.5 mg/1 tablet, listed with the FDA by Exelan Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Exelan Pharmaceuticals, Inc., NDC labeler code 76282. 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 76282-507 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-507Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0507Add 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
76282-507-05	76282050705	500 TABLET in 1 BOTTLE (76282-507-05)Marketed from Mar 15, 2022
76282-507-10	76282050710	1000 TABLET in 1 BOTTLE (76282-507-10)Marketed from Mar 15, 2022
76282-507-90	76282050790	90 TABLET in 1 BOTTLE (76282-507-90)Marketed from Mar 15, 2022

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: Exelan Pharmaceuticals, Inc.NDC labeler code 76282
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206367
Marketing start: Mar 15, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 76282-507_17a72ab9-cae7-43c3-9913-fff5e038970bSPL ID 17a72ab9-cae7-43c3-9913-fff5e038970bSPL set ID 1a24433f-4464-4c6d-9456-ed1ce38e8ec4RxCUI 197361, 308135, 308136UNII 864V2Q084HUPC 0376282509051, 0376282507057, 0376282509907, 0376282509105, 0376282507101, 0376282508054, 0376282508108, 0376282508900, 0376282507903
Pharmacologic class: 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

N476282050705 followed by a unit qualifier and the quantity

Package 76282-0507-05. 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 Mar 12, 2022.

Indications (excerpt from the label)

Amlodipine besylate tablets, USP 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, USP are 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 tablet…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76282-507

What is NDC 76282-507?: 76282-507 is the product NDC for Amlodipine besylate, Amlodipine besylate 2.5 mg/1 tablet, listed with the FDA by Exelan Pharmaceuticals, Inc.. It has 3 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?: Exelan Pharmaceuticals, Inc., NDC labeler code 76282. 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 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	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 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 206367

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

FDA NDC Directory listings under ANDA 206367
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-508
Amlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-509