amlodipine besylate NDC 71610-469

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-469Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0469Add 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
71610-469-30	71610046930	30 TABLET in 1 BOTTLE (71610-469-30)Marketed from Sep 29, 2020
71610-469-45	71610046945	45 TABLET in 1 BOTTLE (71610-469-45)Marketed from Sep 29, 2020
71610-469-53	71610046953	60 TABLET in 1 BOTTLE (71610-469-53)Marketed from Oct 17, 2022
71610-469-60	71610046960	90 TABLET in 1 BOTTLE (71610-469-60)Marketed from Oct 17, 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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 019787
Marketing start: Jun 24, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 71610-469_d8b9ec72-8206-48b8-a474-660fc685c17dSPL ID d8b9ec72-8206-48b8-a474-660fc685c17dSPL set ID f3482709-c5c3-4bd0-8067-ad57f31bb525RxCUI 308135UNII 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

N471610046930 followed by a unit qualifier and the quantity

Package 71610-0469-30. 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 Oct 18, 2022.

Indications (excerpt from the label)

Amlodipine besylate 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 tablet 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 are indicated for …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019787

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

FDA NDC Directory listings under NDA 019787
Product	Strength	Form · route	Labeler	Product NDC
Norvascamlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	PFIZER LABORATORIES DIV PFIZER INC	0069-1540
Norvascamlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	PFIZER LABORATORIES DIV PFIZER INC	0069-1530
amlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	59762-2135
amlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	59762-2010
amlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	59762-2242
Norvascamlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	PFIZER LABORATORIES DIV PFIZER INC	0069-1520
Norvascamlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	Viatris Specialty LLC	58151-354
Norvascamlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Viatris Specialty LLC	58151-353
Norvascamlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	Viatris Specialty LLC	58151-355