Quick answers
- What is Pravastatin sodium used for?
- The FDA-approved label (Pravastatin sodium, Remedyrepack Inc., September 10, 2026) says: “Pravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pravastatin sodium have a boxed warning?
- No. None of the 118 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pravastatin sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pravastatin sodium been recalled?
- FDA enforcement reports list 13 recalls of products of this medicine; the newest started March 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Pravastatin sodium?
- 34 companies list prescription products of Pravastatin sodium in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Aurobindo Pharma Limited.
What Pravastatin sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Pravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). …
— FDA label: Pravastatin sodium, Remedyrepack Inc., effective September 10, 2026. Read the full label on DailyMed →
The FDA has 118 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.
The label quoted above has no boxed warning.
0 of 118 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 185 in the FDA NDC Directory |
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 |
|---|---|---|
| pravastatin sodium 10 mg tablet | Generic | $0.0574 per tablet |
| pravastatin sodium 20 mg tablet | Generic | $0.0566 per tablet |
| pravastatin sodium 40 mg tablet | Generic | $0.0789 per tablet |
| pravastatin sodium 80 mg tablet | Generic | $0.1365 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.
- Bryant Ranch Prepack31 products
- A-S Medication Solutions25 products
- Aurobindo Pharma Limited9 products
- NCS HealthCare of KY, LLC dba Vangard Labs8 products
- Preferred Pharmaceuticals Inc.8 products
- Northwind Health Company, LLC7 products
- NuCare Pharmaceuticals, Inc.6 products
- Direct_Rx5 products
- Remedyrepack Inc.5 products
- PD-Rx Pharmaceuticals, Inc.4 products
- Golden State Medical Supply, Inc.4 products
- Chartwell RX, LLC4 products
- Lupin Pharmaceuticals, Inc.4 products
- Cipla USA Inc.4 products
- NorthStar RxLLC4 products
- Accord Healthcare Inc.4 products
- Amici Pharma, Inc.4 products
- Biocon Pharma Inc.4 products
- Proficient Rx LP4 products
- AvPAK4 products
- Dr. Reddy's Laboratories Limited4 products
- Apotex Corp.4 products
- Aphena Pharma Solutions - Tennessee, LLC4 products
- Glenmark Pharmaceuticals Inc., USA4 products
- Major Pharmaceuticals3 products
- American Health Packaging3 products
- Coupler LLC3 products
- Quallent3 products
- Cardinal Health 107, LLC3 products
- Safecor Health LLC2 products
- Teva Pharmaceuticals, Inc.1 product
- Quality Care Products, LLC1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Lake Erie Medical DBA Quality Care Products LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (10)
- ANDA076056Aurobindo Pharma USA · April 24, 2006
- ANDA076341Apotex · October 23, 2006
- ANDA076714DR Reddys Labs Inc · October 23, 2006
- ANDA077987Glenmark Pharms Ltd · May 11, 2007
- ANDA077917Chartwell Rx · January 8, 2008
- ANDA077793Aurobindo Pharma USA · January 15, 2008
- ANDA077491Pharmazone · February 11, 2008
- ANDA207068Accord Hlthcare · November 17, 2016
- ANDA203367Aurobindo Pharma · February 2, 2017
- ANDA209869Biocon Pharma · April 13, 2018
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.
-
March 13, 2025 · Class II · Ongoing · D-0325-2025
CGMP Deviations
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 — Glenmark Pharmaceuticals Inc., USA
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March 13, 2025 · Class II · Ongoing · D-0341-2025
CGMP Deviations
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man — Glenmark Pharmaceuticals Inc., USA
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March 13, 2025 · Class II · Ongoing · D-0350-2025
CGMP Deviations
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampu — Glenmark Pharmaceuticals Inc., USA
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March 13, 2025 · Class II · Ongoing · D-0349-2025
CGMP Deviations
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01 — Glenmark Pharmaceuticals Inc., USA
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June 28, 2024 · Class II · Ongoing · D-0612-2024
Failed Dissolution Specifications: results below specifications
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, — Glenmark Pharmaceuticals Inc., USA
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February 7, 2023 · Class II · Terminated · D-0424-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-0 — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0421-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0423-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729- — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0422-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009 — Accord Healthcare, Inc.
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March 25, 2019 · Class II · Terminated · D-1120-2019
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for — Glenmark Pharmaceuticals Inc., USA
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November 17, 2017 · Class II · Terminated · D-0092-2018
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09 — Lupin Limited
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July 11, 2017 · Class III · Terminated · D-1038-2017
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 IND — Dr. Reddy's Laboratories, Inc.
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April 5, 2013 · Class III · Terminated · D-330-2013
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430 — Glenmark Generics Inc., USA
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) | 904458, 904467, 904475, 904481 |
|---|---|
| SPL set ID of the quoted label | 6cef5e92-26b7-435c-878f-72a05a624560 |
| FDA labels (SPL) | 118 |
| FDA applications | 10 ANDA |
| Active ingredients (FDA) | PRAVASTATIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pravastatin sodium, Remedyrepack Inc., effective September 10, 2026; 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 →