Amlodipine Besylate NDC 71335-1278

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1278Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1278Add 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
71335-1278-0	71335127800	5 TABLET in 1 BOTTLE (71335-1278-0)Marketed from Jul 23, 2015
71335-1278-1	71335127801	30 TABLET in 1 BOTTLE (71335-1278-1)Marketed from Jul 23, 2015
71335-1278-2	71335127802	90 TABLET in 1 BOTTLE (71335-1278-2)Marketed from Jul 23, 2015
71335-1278-3	71335127803	60 TABLET in 1 BOTTLE (71335-1278-3)Marketed from Jul 23, 2015
71335-1278-4	71335127804	100 TABLET in 1 BOTTLE (71335-1278-4)Marketed from Jul 23, 2015
71335-1278-5	71335127805	180 TABLET in 1 BOTTLE (71335-1278-5)Marketed from Jul 23, 2015
71335-1278-6	71335127806	120 TABLET in 1 BOTTLE (71335-1278-6)Marketed from Jul 23, 2015
71335-1278-7	71335127807	10 TABLET in 1 BOTTLE (71335-1278-7)Marketed from Jul 23, 2015
71335-1278-8	71335127808	500 TABLET in 1 BOTTLE (71335-1278-8)Marketed from Jul 23, 2015
71335-1278-9	71335127809	1000 TABLET in 1 BOTTLE (71335-1278-9)Marketed from Jul 23, 2015

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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078925
Marketing start: Oct 20, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 71335-1278_19f9229f-2ed5-4d1a-a854-2fe6a1b10ceeSPL ID 19f9229f-2ed5-4d1a-a854-2fe6a1b10ceeSPL set ID 1b449c22-0181-4a50-94b3-26139b90b978RxCUI 197361, 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

N471335127800 followed by a unit qualifier and the quantity

Package 71335-1278-00. 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 Aug 7, 2024.

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)

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	0615-8654
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	QPharma, Inc.	42708-204
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7985
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Proficient Rx LP	71205-596
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	American Health Packaging	60687-488
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-1971
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-2981
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8429
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	American Health Packaging	60687-496
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-0945
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	0615-8430
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-016
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8431
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Ascend Laboratories, LLC	67877-901
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-017
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Ascend Laboratories, LLC	67877-900
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Ascend Laboratories, LLC	67877-902
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Coupler LLC	67046-0328
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-3126

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