NDC codes

FDA NDC Directory
Product NDC (as listed)65162-414Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65162-0414Add 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
65162-414-036516204140330 TABLET in 1 BOTTLE (65162-414-03)Marketed from Sep 30, 2013
65162-414-096516204140990 TABLET in 1 BOTTLE (65162-414-09)Marketed from Sep 30, 2013
65162-414-11651620414111000 TABLET in 1 BOTTLE (65162-414-11)Marketed from Sep 30, 2013
65162-414-5065162041450500 TABLET in 1 BOTTLE (65162-414-50)Marketed from Sep 30, 2013

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)
Clopidogrel
Generic name (nonproprietary)
clopidogrel
Active ingredients
Clopidogrel bisulfate — 75 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203751
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
Identifiers
Product ID 65162-414_360ed8dd-4f92-46fc-b31b-abe0d75e9bb3SPL ID 360ed8dd-4f92-46fc-b31b-abe0d75e9bb3SPL set ID 0d010775-1160-4b2e-a928-563a02edd191RxCUI 309362UNII 08I79HTP27
Pharmacologic class
P2Y12 Platelet Inhibitor

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

N465162041403 followed by a unit qualifier and the quantity

Package 65162-0414-03. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Clopidogrel is a P2Y 12 platelet inhibitor indicated for: Acute coronary syndrome For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2) 1.1 Acute Coronary Syndrome (ACS) Clopidogrel tablets are indicated to reduce the rate of myocardial infar…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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