AMLODIPINE BESYLATE 10 mg (amlodipine besylate) NDC 71610-830

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-830Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0830Add 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
71610-830-30	71610083030	30 TABLET in 1 BOTTLE (71610-830-30)Marketed from May 13, 2024
71610-830-45	71610083045	45 TABLET in 1 BOTTLE (71610-830-45)Marketed from May 13, 2024
71610-830-60	71610083060	90 TABLET in 1 BOTTLE (71610-830-60)Marketed from Dec 19, 2024

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 10 mgSuffix: 10 mg
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: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078414
Marketing start: Oct 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 71610-830_29b99df4-d06a-8ad8-e063-6294a90a2ff4SPL ID 29b99df4-d06a-8ad8-e063-6294a90a2ff4SPL set ID 1871ddaf-ed2c-c3ce-e063-6394a90a1beeRxCUI 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

N471610083030 followed by a unit qualifier and the quantity

Package 71610-0830-30. 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 Dec 20, 2024.

Indications (excerpt from the label)

Amlodipine besylate tablets are 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 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 tablets are in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078414

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

FDA NDC Directory listings under ANDA 078414
Product	Strength	Form · route	Labeler	Product NDC
AMLODIPINE BESYLATE 10 mgamlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	Proficient Rx LP	82804-971
AMLODIPINE BESYLATE 2.5 mgamlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-802
AMLODIPINE BESYLATE 10 mgamlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	Oxford Pharmaceuticals, LLC	69584-023
AMLODIPINE BESYLATE 2.5 mgamlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Oxford Pharmaceuticals, LLC	69584-021
AMLODIPINE BESYLATE 5 mgamlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	Oxford Pharmaceuticals, LLC	69584-022
AMLODIPINE BESYLATE 10 mgamlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3453
AMLODIPINE BESYLATE 5 mgamlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-687
AMLODIPINE BESYLATE 10 mgamlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-978
AMLODIPINE BESYLATE 5 mgamlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-985
AMLODIPINE BESYLATE 10 mgamlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8451
AMLODIPINE BESYLATE 2.5 mgamlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-260
AMLODIPINE BESYLATE 5 mgamlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-261
AMLODIPINE BESYLATE 10 mgamlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-262
AMLODIPINE BESYLATE 5 mgamlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	Proficient Rx LP	82804-970
AMLODIPINE BESYLATE 2.5 mgamlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Proficient Rx LP	82804-969