Quick answers
- What is Ramipril used for?
- The FDA-approved label (Ramipril, BluePoint Laboratories, September 4, 2026) says: “Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ramipril have a boxed warning?
- Yes. The FDA label for Ramipril has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ramipril?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ramipril been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started August 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ramipril?
- 17 companies list prescription products of Ramipril in the FDA NDC Directory, including A-S Medication Solutions, Northwind Health Company, LLC and Proficient Rx LP.
What Ramipril is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics. …
— FDA label: Ramipril, BluePoint Laboratories, effective September 4, 2026. Read the full label on DailyMed →
The FDA has 30 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. Its heading: WARNING: FETAL TOXICITY
. Read it on the full label →
29 of 30 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 69 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 |
|---|---|---|
| ramipril 1.25 mg capsule | Generic | $0.0802 per capsule |
| ramipril 10 mg capsule | Generic | $0.0642 per capsule |
| ramipril 2.5 mg capsule | Generic | $0.0494 per capsule |
| ramipril 5 mg capsule | Generic | $0.0519 per capsule |
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
- Northwind Health Company, LLC7 products
- Proficient Rx LP6 products
- Bryant Ranch Prepack5 products
- Rising Pharma Holdings, Inc.4 products
- Chartwell RX, LLC4 products
- Aurobindo Pharma Limited4 products
- Zydus Lifesciences Limited4 products
- BluePoint Laboratories4 products
- Lupin Pharmaceuticals, Inc.4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Hikma Pharmaceuticals USA Inc.4 products
- Exelan Pharmaceuticals Inc.4 products
- Remedyrepack Inc.3 products
- GSMS, Incorporated3 products
- NuCare Pharmaceuticals, Inc.1 product
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (6)
- ANDA077626Lupin · June 9, 2008
- ANDA077900Hikma · June 18, 2008
- ANDA078745Chartwell Molecular · June 18, 2008
- ANDA079116Solgen · June 20, 2008
- ANDA078832Zydus Pharms USA · September 2, 2008
- ANDA091604Aurobindo Pharma Ltd · June 8, 2011
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 24, 2026 · Class II · Ongoing · D-0831-2026
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: — Hikma Pharmaceuticals USA INC.
-
October 23, 2024 · Class II · Terminated · D-0053-2025
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured — Lupin Pharmaceuticals Inc.
-
October 23, 2024 · Class II · Terminated · D-0054-2025
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured — Lupin Pharmaceuticals Inc.
-
October 23, 2024 · Class II · Terminated · D-0052-2025
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufacture — Lupin Pharmaceuticals 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) | 198188, 198189, 261962, 845488 |
|---|---|
| SPL set ID of the quoted label | 45707435-4fc8-457e-9ff2-02d7be9b4a6e |
| FDA labels (SPL) | 30 |
| FDA applications | 6 ANDA |
| Active ingredients (FDA) | RAMIPRIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ramipril, BluePoint Laboratories, effective September 4, 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 →