Prescription drug · ANDA

Clopidogrel (clopidogrel bisulfate) NDC 69367-194

Clopidogrel bisulfate 300 mg/1 · Tablet, Film coated · Oral · Westminster Pharmaceuticals, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)69367-194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69367-0194Add 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
69367-194-0569367019405500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-194-05)Marketed from Jul 27, 2018
69367-194-306936701943030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-194-30)Marketed from Jul 27, 2018

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 bisulfate
Active ingredients
Clopidogrel bisulfate — 300 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204165
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
Identifiers
Product ID 69367-194_175ba166-6dc4-41d9-a75e-853cb6d47aebSPL ID 175ba166-6dc4-41d9-a75e-853cb6d47aebSPL set ID bb3b5e96-e629-4db5-8ad5-40c17c6dae18RxCUI 309362, 749196UNII 08I79HTP27UPC 0369367194303
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

N469367019405 followed by a unit qualifier and the quantity

Package 69367-0194-05. 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 has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) – For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1 ) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and stroke in p…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204165

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

FDA NDC Directory listings under ANDA 204165
ProductStrengthForm · routeLabelerProduct NDC
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralProficient Rx LP63187-639
Clopidogrelclopidogrel bisulfateClopidogrel bisulfate 300 mg/1Tablet, Film coatedOralProficient Rx LP82804-986
Clopidogrel bisulfateClopidogrel bisulfate 300 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals Inc50228-121
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals Inc50228-124
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2212
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8625
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5277
ClopidogrelClopidogrel bisulfate 75 mg/1TabletOralVensun Pharmaceuticals, Inc.42543-713
ClopidogrelClopidogrel bisulfate 300 mg/1TabletOralVensun Pharmaceuticals, Inc.42543-714
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-7700
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1646
Clopidogrelclopidogrel bisulfateClopidogrel bisulfate 300 mg/1Tablet, Film coatedOralAvPAK50268-184
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4110
Clopidogrelclopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-200
Clopidogrel bisulfateClopidogrel bisulfate 75 mg/1Tablet, Film coatedOralRADHA PHARMACEUTICALS, INC.77771-124
Clopidogrel bisulfateClopidogrel bisulfate 300 mg/1Tablet, Film coatedOralRADHA PHARMACEUTICALS, INC.77771-121

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Clopidogrel (clopidogrel bisulfate) NDC 69367-194 | Med-Code