Quick answers
- What is Methyldopa used for?
- The FDA-approved label (Methyldopa, Chartwell RX, LLC, March 26, 2025) says: “Hypertension.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methyldopa have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Methyldopa?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Methyldopa been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Methyldopa?
- 2 companies list prescription products of Methyldopa in the FDA NDC Directory, including Chartwell RX, LLC and Rising Pharma Holdings, Inc..
What Methyldopa is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Hypertension.
— FDA label: Methyldopa, Chartwell RX, LLC, effective March 26, 2025. Read the full label on DailyMed →
The FDA has 2 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 2 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 | 4 in the FDA NDC Directory |
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.
- Chartwell RX, LLC2 products
- Rising Pharma Holdings, Inc.2 products
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 |
|---|---|---|---|
| NDA018934 METHYLDOPA | Chartwell Rx | June 29, 1984 | 27, latest August 5, 1998 1998: Labeling · 1998: Labeling · 1996: Labeling |
Generic approvals (1)
- ANDA070076Rising · April 18, 1985
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) | 197956, 197958 |
|---|---|
| SPL set ID of the quoted label | e1114a58-9ab5-486e-85ed-360365b06396 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA018934, 1 ANDA |
| Active ingredients (FDA) | METHYLDOPA |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Methyldopa, Chartwell RX, LLC, effective March 26, 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 →