Clopidogrel bisulfate NDC 71335-1646

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1646Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1646Add 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 NDC	11-digit (billing)	Package
71335-1646-1	71335164601	90 TABLET, FILM COATED in 1 BOTTLE (71335-1646-1)Marketed from Jun 16, 2020
71335-1646-2	71335164602	30 TABLET, FILM COATED in 1 BOTTLE (71335-1646-2)Marketed from Jul 6, 2020
71335-1646-3	71335164603	60 TABLET, FILM COATED in 1 BOTTLE (71335-1646-3)Marketed from Jun 17, 2020
71335-1646-4	71335164604	20 TABLET, FILM COATED in 1 BOTTLE (71335-1646-4)Marketed from Dec 28, 2021
71335-1646-5	71335164605	10 TABLET, FILM COATED in 1 BOTTLE (71335-1646-5)Marketed from Dec 28, 2021

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): Clopidogrel bisulfate
Generic name (nonproprietary): clopidogrel bisulfate
Active ingredients: Clopidogrel bisulfate — 75 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204165
Marketing start: Sep 15, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
Identifiers: Product ID 71335-1646_c87019f9-85a2-4438-8b1c-950b2676e2d5SPL ID c87019f9-85a2-4438-8b1c-950b2676e2d5SPL set ID 7c4b3bc3-8f3b-4232-835d-e37d93b92c3eRxCUI 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

N471335164601 followed by a unit qualifier and the quantity

Package 71335-1646-01. 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 Nov 6, 2023. 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 pat…

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
Product	Strength	Form · route	Labeler	Product NDC
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-639
Clopidogrelclopidogrel bisulfate	Clopidogrel bisulfate 300 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-986
Clopidogrel bisulfate	Clopidogrel bisulfate 300 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals Inc	50228-121
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals Inc	50228-124
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2212
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8625
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5277
Clopidogrel	Clopidogrel bisulfate 75 mg/1	TabletOral	Vensun Pharmaceuticals, Inc.	42543-713
Clopidogrel	Clopidogrel bisulfate 300 mg/1	TabletOral	Vensun Pharmaceuticals, Inc.	42543-714
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-7700
Clopidogrelclopidogrel bisulfate	Clopidogrel bisulfate 300 mg/1	Tablet, Film coatedOral	AvPAK	50268-184
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4110
Clopidogrelclopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-200
Clopidogrelclopidogrel bisulfate	Clopidogrel bisulfate 300 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-194
Clopidogrel bisulfate	Clopidogrel bisulfate 75 mg/1	Tablet, Film coatedOral	RADHA PHARMACEUTICALS, INC.	77771-124
Clopidogrel bisulfate	Clopidogrel bisulfate 300 mg/1	Tablet, Film coatedOral	RADHA PHARMACEUTICALS, INC.	77771-121