AMLODIPINE BESYLATE 5 mg (amlodipine besylate) NDC 82804-970

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-970Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0970Add 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
82804-970-00	82804097000	100 TABLET in 1 BOTTLE (82804-970-00)Marketed from Feb 13, 2025
82804-970-11	82804097011	1000 TABLET in 1 BOTTLE (82804-970-11)Marketed from Feb 13, 2025
82804-970-30	82804097030	30 TABLET in 1 BOTTLE (82804-970-30)Marketed from Feb 13, 2025
82804-970-55	82804097055	500 TABLET in 1 BOTTLE (82804-970-55)Marketed from Feb 13, 2025
82804-970-60	82804097060	60 TABLET in 1 BOTTLE (82804-970-60)Marketed from Feb 13, 2025
82804-970-72	82804097072	120 TABLET in 1 BOTTLE (82804-970-72)Marketed from Feb 13, 2025
82804-970-90	82804097090	90 TABLET in 1 AMPULE (82804-970-90)Marketed from Feb 13, 2025

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 5 mgSuffix: 5 mg
Generic name (nonproprietary): amlodipine besylate
Active ingredients: Amlodipine besylate — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Proficient Rx LP
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 82804-970_6313edc5-d2d5-44a1-a06f-7f7829c870d2SPL ID 6313edc5-d2d5-44a1-a06f-7f7829c870d2SPL set ID 6313edc5-d2d5-44a1-a06f-7f7829c870d2RxCUI 197361, 308135, 308136UNII 864V2Q084HUPC 0382804969302, 0382804970308, 0382804971305
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

N482804097000 followed by a unit qualifier and the quantity

Package 82804-0970-00. 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 Feb 1, 2025.

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 ) o 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 ) o Chronic Stable Angina o Vasospastic Angina (Prinzmetal's or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate ta…

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	Aphena Pharma Solutions - Tennessee, LLC	71610-830
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 2.5 mgamlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Proficient Rx LP	82804-969