Quick answers
- What is Captopril used for?
- The FDA-approved label (Captopril, Amici Pharma, Inc., September 14, 2026) says: “Hypertension Captopril tablets are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Captopril have a boxed warning?
- Yes. The FDA label for Captopril 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 Captopril?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Captopril been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Captopril?
- 13 companies list prescription products of Captopril in the FDA NDC Directory, including Method Pharmaceuticals, LLC, Amici Pharma, Inc. and AiPing Pharmaceutical, Inc..
What Captopril is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Hypertension Captopril tablets are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. …
— FDA label: Captopril, Amici Pharma, Inc., effective September 14, 2026. Read the full label on DailyMed →
The FDA has 15 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 →
15 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 47 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 |
|---|---|---|
| captopril 100 mg tablet | Generic | $0.6344 per tablet |
| captopril 12.5 mg tablet | Generic | $0.2466 per tablet |
| captopril 25 mg tablet | Generic | $0.1636 per tablet |
| captopril 50 mg tablet | Generic | $0.4454 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.
- Method Pharmaceuticals, LLC8 products
- Amici Pharma, Inc.4 products
- AiPing Pharmaceutical, Inc.4 products
- Solco Healthcare US, LLC4 products
- Ajanta Pharma USA Inc.4 products
- Camber Pharmaceuticals, Inc.4 products
- Hikma Pharmaceuticals USA Inc.4 products
- Golden State Medical Supply, Inc.4 products
- AvKARE3 products
- Bryant Ranch Prepack3 products
- American Health Packaging2 products
- Major Pharmaceuticals2 products
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (6)
- ANDA074477Prinston Inc · February 13, 1996
- ANDA074505Hikma · February 13, 1996
- ANDA074677Andas 5 Holding · May 30, 1997
- ANDA074737Macleods Pharms · October 28, 1998
- ANDA212809Ajanta Pharma Ltd · December 13, 2019
- ANDA214442Aiping Pharm Inc · January 27, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 308962, 308963, 308964, 317173 |
|---|---|
| SPL set ID of the quoted label | 1395ba5b-2fc9-41ff-9c43-e0740d781dee |
| FDA labels (SPL) | 15 |
| FDA applications | 6 ANDA |
| Active ingredients (FDA) | CAPTOPRIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Captopril, Amici Pharma, Inc., effective September 14, 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 →