NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1865Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1865Add 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 NDC11-digit (billing)PackageCopy
71335-1865-0713351865007 TABLET in 1 BOTTLE, PLASTIC (71335-1865-0)Marketed from May 22, 2024
71335-1865-17133518650130 TABLET in 1 BOTTLE, PLASTIC (71335-1865-1)Marketed from May 22, 2024
71335-1865-27133518650290 TABLET in 1 BOTTLE, PLASTIC (71335-1865-2)Marketed from May 22, 2024
71335-1865-37133518650360 TABLET in 1 BOTTLE, PLASTIC (71335-1865-3)Marketed from May 22, 2024
71335-1865-471335186504120 TABLET in 1 BOTTLE, PLASTIC (71335-1865-4)Marketed from May 22, 2024
71335-1865-571335186505100 TABLET in 1 BOTTLE, PLASTIC (71335-1865-5)Marketed from May 22, 2024
71335-1865-671335186506800 TABLET in 1 BOTTLE, PLASTIC (71335-1865-6)Marketed from May 22, 2024
71335-1865-7713351865071000 TABLET in 1 BOTTLE, PLASTIC (71335-1865-7)Marketed from May 22, 2024
71335-1865-871335186508180 TABLET in 1 BOTTLE, PLASTIC (71335-1865-8)Marketed from May 22, 2024
71335-1865-97133518650910 TABLET in 1 BOTTLE (71335-1865-9)Marketed from May 22, 2024

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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203245
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 71335-1865_ef2eb5d8-d32f-4b45-af1d-5efd4b9ebfb2SPL ID ef2eb5d8-d32f-4b45-af1d-5efd4b9ebfb2SPL set ID b1151904-5085-49bd-94ec-cb2894f4eb10RxCUI 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

N471335186500 followed by a unit qualifier and the quantity

Package 71335-1865-00. 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 .

Indications (excerpt from the label)

Amlodipine besylate tablets are calcium channel blockers 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 indi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203245

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

FDA NDC Directory listings under ANDA 203245
ProductStrengthForm · routeLabelerProduct NDC
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralProficient Rx LP71205-599
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralBryant Ranch Prepack71335-2359
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-399
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralREMEDYREPACK INC.70518-4464
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-539
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8543
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralA-S Medication Solutions50090-6809
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralA-S Medication Solutions50090-6808
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralNorthwind Health Company, LLC82868-031
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2305
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralDirect_Rx72189-520
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralDirect_Rx72189-529
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralA-S Medication Solutions50090-6876
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralA-S Medication Solutions50090-6877
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-398
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-396
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-397
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralProficient Rx LP71205-506
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralQuality Care Products, LLC83008-035
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-445

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