NDC codes

FDA NDC Directory
Product NDC (as listed)43063-764Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0764Add 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
43063-764-30430630764304306307643030 TABLET in 1 BOTTLE, PLASTIC (43063-764-30)Marketed from May 8, 2017

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 — 2.5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077073
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 43063-764_47d29cab-fc5f-977d-e063-6294a90a6bf1SPL ID 47d29cab-fc5f-977d-e063-6294a90a6bf1SPL set ID e01efe66-2f31-4261-92ca-0b41f27104daRxCUI 308136UNII 864V2Q084HUPC 0343063764305
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

N443063076430 followed by a unit qualifier and the quantity

Package 43063-0764-30. 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 .

Indications (excerpt from the label)

Amlodipine besylate tablet, USP 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) 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 tabl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43063-764

What is NDC 43063-764?
43063-764 is the product NDC for Amlodipine Besylate, Amlodipine besylate 2.5 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amlodipine Besylate.
What is the active ingredient?
Amlodipine besylate.
Who is the labeler?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amlodipine Besylate?
167 other product NDCs are listed under this name. See all Amlodipine Besylate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Amlodipine Besylate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralAmerican Health Packaging60687-96160687-0961-01
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralAmerican Health Packaging60687-97260687-0972-01
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralDirect_Rx72189-68972189-0689-90
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralCoupler LLC67046-115767046-1157-03
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralUnit Dose Solutions, Inc.87441-01687441-0016-01
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralUnit Dose Solutions, Inc.87441-01787441-0017-01
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralSafecor Health LLC48433-15548433-0155-20
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralSafecor Health LLC48433-15648433-0156-20
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralSafecor Health LLC48433-15748433-0157-20
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralREMEDYREPACK INC.70518-462970518-4629-0070518-4629-02

All 168 Amlodipine Besylate NDCs

Other NDCs under ANDA 077073

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

FDA NDC Directory listings under ANDA 077073
ProductStrengthForm · routeLabelerProduct NDC
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralNorthwind Health Company, LLC51655-044
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralNorthwind Health Company, LLC51655-869
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralProficient Rx LP63187-914
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralRedpharm Drug67296-2297
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-1980
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8627
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralCipla USA Inc.69097-126
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralCipla USA Inc.69097-127
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralCipla USA Inc.69097-128
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralREMEDYREPACK INC.70518-0297
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralREMEDYREPACK INC.70518-0835
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralBryant Ranch Prepack71335-0218
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralBryant Ranch Prepack71335-0473
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-026
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-027
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-028

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