Quick answers
- What is Clopidogrel used for?
- The FDA-approved label (Plavix, Sanofi-Aventis U.S. LLC, May 30, 2025) says: “Plavix 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]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. – For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clopidogrel have a boxed warning?
- Yes. The FDA label for Plavix has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Clopidogrel?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clopidogrel been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started August 2, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Clopidogrel?
- 36 companies list prescription products of Clopidogrel in the FDA NDC Directory, including A-S Medication Solutions, NuCare Pharmaceuticals, Inc. and Proficient Rx LP.
What Clopidogrel is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Plavix 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]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. – For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. …
— FDA label: Plavix, Sanofi-Aventis U.S. LLC, effective May 30, 2025. Read the full label on DailyMed →
The FDA has 55 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
55 of 55 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 67 in the FDA NDC Directory |
| Brand names | Plavix |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| clopidogrel bisulfate 300 mg tablet, film coated | Generic | $5.29 per tablet |
| clopidogrel bisulfate 75 mg tablet | Generic | $0.0469 per tablet |
| clopidogrel bisulfate 75 mg tablet, film coated | Generic | $0.0469 per tablet |
| clopidogrel bisulfate 75 mg tablet, film coated | Brand: Plavix | $8.21 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions7 products
- NuCare Pharmaceuticals, Inc.4 products
- Proficient Rx LP4 products
- Remedyrepack Inc.4 products
- Bryant Ranch Prepack4 products
- Vensun Pharmaceuticals, Inc.2 products
- Dr. Reddy's Laboratories Limited2 products
- Sanofi-Aventis U.S. LLC2 products
- Quallent Pharmaceuticals Health LLC2 products
- Westminster Pharmaceuticals, LLC2 products
- Dr. Reddy's Laboratories Inc.2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Radha Pharmaceuticals, Inc.2 products
- ScieGen Pharmaceuticals, Inc.2 products
- American Health Packaging2 products
- Preferred Pharmaceuticals Inc.2 products
- Apotex Corp.2 products
- Camber Pharmaceuticals, Inc.2 products
- Aphena Pharma Solutions - Tennessee, LLC1 product
- NorthStar RxLLC1 product
- Cardinal Health 107, LLC1 product
- Major Pharmaceuticals1 product
- Rising Pharma Holdings, Inc.1 product
- Ascend Laboratories, LLC1 product
- Legacy Pharmaceutical Packaging, LLC1 product
- Torrent Pharmaceuticals Limited1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Macleods Pharmaceuticals Limited1 product
- AvPAK1 product
- McKesson Corporation dba SKY Packaging1 product
- Aurobindo Pharma Limited1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Redpharm Drug1 product
- Novadoz Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020839 PLAVIX | Sanofi Aventis Us | November 17, 1997 | 57, latest September 12, 2023 2023: Labeling · 2022: Labeling · 2021: Labeling |
Generic approvals (14)
- ANDA076273DR Reddys · January 14, 2008
- ANDA076274Apotex Inc · May 17, 2012
- ANDA076999Teva · May 17, 2012
- ANDA090494Sun Pharm · May 17, 2012
- ANDA090540Aurobindo Pharma Ltd · May 17, 2012
- ANDA090844Torrent Pharms Ltd · May 17, 2012
- ANDA091023DR Reddys Labs Ltd · May 17, 2012
- ANDA202928Macleods Pharms · February 10, 2014
- ANDA203751Amneal Pharms · April 11, 2014
- ANDA204165Sciegen Pharms · September 15, 2014
- ANDA204359Rising · February 2, 2017
- ANDA205345Hetero Labs Ltd V · August 4, 2023
- ANDA203632Alkem Labs Ltd · December 8, 2023
- ANDA215388Msn · September 20, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 2, 2021 · Class II · Terminated · D-0787-2021
Presence of foreign matter
Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh, INDIA NDC 33342-060- — Macleods Pharma Usa Inc
-
December 10, 2018 · Class II · Terminated · D-0294-2019
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31 — Dr. Reddy's Laboratories, Inc.
-
November 7, 2018 · Class II · Terminated · D-0283-2019
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31 — Dr. Reddy's Laboratories, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 213169, 309362, 749196, 749198 |
|---|---|
| SPL set ID of the quoted label | de8b0b67-eb25-4684-83b5-7ad785314227 |
| FDA labels (SPL) | 55 |
| FDA applications | NDA020839, 14 ANDA |
| Active ingredients (FDA) | CLOPIDOGREL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Plavix, Sanofi-Aventis U.S. LLC, effective May 30, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →