Quick answers
- What is Demeclocycline used for?
- The FDA-approved label (Demeclocycline Hydrochloride, Amneal Pharmaceuticals of New York LLC, April 2, 2026) says: “Demeclocycline hydrochloride tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Demeclocycline have a boxed warning?
- No. None of the 5 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Demeclocycline?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Demeclocycline been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Demeclocycline?
- 5 companies list prescription products of Demeclocycline in the FDA NDC Directory, including PuraCap Laboratories LLC, Epic Pharma, LLC and Amneal Pharmaceuticals LLC.
What Demeclocycline is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Demeclocycline hydrochloride tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae …
— FDA label: Demeclocycline Hydrochloride, Amneal Pharmaceuticals of New York LLC, effective April 2, 2026. Read the full label on DailyMed →
The FDA has 5 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.
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 5 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 | 10 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 |
|---|---|---|
| demeclocycline hydrochloride 150 mg tablet | Generic | $2.12 per tablet |
| demeclocycline hydrochloride 150 mg tablet, film coated | Generic | $2.12 per tablet |
| demeclocycline hydrochloride 300 mg tablet | Generic | $2.99 per tablet |
| demeclocycline hydrochloride 300 mg tablet, film coated | Generic | $2.99 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.
- PuraCap Laboratories LLC2 products
- Epic Pharma, LLC2 products
- Amneal Pharmaceuticals LLC2 products
- American Health Packaging2 products
- Amneal Pharmaceuticals of New York LLC2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA065425Amneal Pharm · February 27, 2008
- ANDA065447Epic Pharma LLC · August 18, 2015
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) | 905341, 905347 |
|---|---|
| SPL set ID of the quoted label | 539add06-e0a0-401a-b4f6-20776084aa9c |
| FDA labels (SPL) | 5 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | DEMECLOCYCLINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Demeclocycline Hydrochloride, Amneal Pharmaceuticals of New York LLC, effective April 2, 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 →