NDC codes

FDA NDC Directory
Product NDC (as listed)63187-362Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0362Add 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
63187-362-306318703623030 TABLET, FILM COATED in 1 BOTTLE (63187-362-30)Marketed from Aug 1, 2016
63187-362-606318703626060 TABLET, FILM COATED in 1 BOTTLE (63187-362-60)Marketed from Aug 1, 2016
63187-362-906318703629090 TABLET, FILM COATED in 1 BOTTLE (63187-362-90)Marketed from Aug 1, 2016

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, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076999
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63187-362_34f7e985-f275-4c4b-ab35-ffa37e49052bSPL ID 34f7e985-f275-4c4b-ab35-ffa37e49052bSPL set ID 25ed3120-7960-4e87-8422-de5c2026062cRxCUI 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

N463187036230 followed by a unit qualifier and the quantity

Package 63187-0362-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Clopidogrel tablets USP are 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 USP have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. ( 1.1 ) • For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets USP have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076999

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

FDA NDC Directory listings under ANDA 076999
ProductStrengthForm · routeLabelerProduct NDC
ClopidogrelClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4138
ClopidogrelClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-7314

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