Prescription medicine
Ramipril First approved as Altace
Ramipril (Altace) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 17 generic labelers, and pharmacies paid $0.0707 per ramipril 10 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ramipril FDA label on DailyMed (effective August 24, 2026, Lupin Pharmaceuticals, Inc.); the NDA 19901 record on Drugs@FDA; every ramipril label on DailyMed.
Highlights of the record
FDA label of August 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ). WARNING: FETAL TOXICITY When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ).
Used for
From the label: indications and usageRamipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure.
Forms and strengths
- 1.25 mg
- 2.5 mg
- 5 mg
- 10 mg
Capsule.
On the market
- Earliest approval on file
- January 28, 1991 Altace, King Pharms Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 17 first October 24, 2005; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 17 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- August 16, 2039 Vostally oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0707 per capsule Ramipril 10 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest August 24, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 123,138 through July 30, 2026
What is ramipril used for?
From the label: indications and usageRamipril 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 ( 1.1 ). In patients 55 years or older at high risk of developing a major cardiovascular event, Ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes ( 2.2 ). […]
Conditions named in the indications of ramipril's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor.
Source: FDA drug label (Ramipril), Lupin Pharmaceuticals, Inc., effective August 24, 2026 (SPL set a8cdec12-81d1-4ef4-82c0-d05d93c37a07), via openFDA; the full label on DailyMed
Is there a generic for ramipril (Altace)?
The FDA approved the first generic ramipril on October 24, 2005. 17 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ramipril from 17 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Altace capsules; a patent listed only for Vostally oral solution runs to August 16, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1991 earliest approval on file
- 2005 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ramipril (Altace)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0707 per Ramipril 10 mg capsule, up 1% from $0.07 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ramipril 5 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ramipril 1.25 mg capsule | Generic | $0.0804 per capsule | $2.41 | -9% |
| Ramipril 10 mg capsule | Generic | $0.0707 per capsule | $2.12 | +1% |
| Ramipril 2.5 mg capsule | Generic | $0.0473 per capsule | $1.42 | -13% |
| Ramipril 5 mg capsule | Generic | $0.0514 per capsule | $1.54 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ramipril been recalled?
The FDA's Enforcement Report lists 6 recalls naming ramipril since 2013: 0 Class I (the most serious), 5 Class II, 1 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of ramipril and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 24, 2026 | Class II | Hikma Pharmaceuticals USA INC. | Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). |
| October 23, 2024 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor |
| August 30, 2016 | Class III | Actavis Laboratories, FL, Inc. | Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROPAFENONE HCL, Tablet, 150 mg, NDC 00591058201, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ramipril label say about other medicines?
The ramipril label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name ramipril. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aliskiren | contraindications | Do not co-administer aliskiren with ramipril in patients with diabetes ( 4 ). |
| Epinephrine | warnings and precautions | Where there is involvement of the tongue, glottis, or larynx likely to cause airway obstruction, administer appropriate therapy (e.g., subcutaneous epinephrine solution 1:1000 [0.3 mL to 0.5 mL]) promptly [see ADVERSE REACTIONS ( 6 )]. |
| Lithium | drug interactions | Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium; therefore, frequent monitoring of serum lithium levels is recommended. |
| Sacubitril and valsartan | contraindications | Do not administer ramipril capsules within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor ( 4 ). |
| Telmisartan | warnings and precautions | Patients receiving the combination of telmisartan and ramipril did not obtain any benefit in the composite endpoint of cardiovascular death, MI, stroke and heart failure hospitalization compared to monotherapy, but experienced an increased incidence of clinically important renal dysfunction (death, doubling of serum … |
| Temsirolimus | drug interactions | 7.7 mTOR Inhibitors or Other Drugs Known to Cause Angioedema Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema [see WARNINGS AND PRECAUTIONS ( 5.1 )]. |
Other labels that name ramipril
Source: FDA drug label (Ramipril), Lupin Pharmaceuticals, Inc., effective August 24, 2026 (SPL set a8cdec12-81d1-4ef4-82c0-d05d93c37a07), via openFDA; the full label on DailyMed
What do FAERS reports show for ramipril?
The FDA Adverse Event Reporting System holds 123,138 reports that list ramipril among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13,282 are coded as a death and 64,691 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ramipril?
72 other medicines are given the same way (oral) and in the same FDA class as ramipril or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lisinopril | High blood pressure, Heart attack and coronary artery disease | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Enalapril | High blood pressure | 29 labelers | $0.0664 per tablet 10 mg tablet | No current entry |
| Hydrochlorothiazide and lisinopril | High blood pressure | 27 labelers | $0.0293 per tablet 10-12.5 mg tablet | No current entry |
| Amlodipine and benazepril | High blood pressure | 16 labelers | $0.114 per unit 10-20 mg | No current entry |
| Benazepril | High blood pressure | 21 labelers | $0.0789 per tablet 20 mg tablet | No current entry |
| Captopril | High blood pressure | 13 labelers | $0.228 per tablet 12.5 mg tablet | No current entry |
| Quinapril | High blood pressure | 9 labelers | n/a | In shortage |
| Benazepril and hydrochlorothiazide | High blood pressure | 3 labelers | $0.222 per tablet 20-12.5 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ramipril compare with medicines for the same use?
20 side-by-side pages set ramipril beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ramipril
- 72 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Ramipril side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other