Prescription medicine
Demeclocycline First approved as Declomycin
Demeclocycline (Declomycin) is a prescription medicine with an FDA approval on record since 1960. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $2.27 per demeclocycline 150 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the demeclocycline FDA label on DailyMed (effective April 2, 2026, Amneal Pharmaceuticals of New York LLC); the NDA 50262 record on Drugs@FDA; every demeclocycline label on DailyMed.
Highlights of the record
FDA label of April 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDemeclocycline 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;
Forms and strengths
- 150 mg
- 300 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- January 14, 1960 Declomycin, Lederle; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first March 22, 2004; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.27 per tablet Demeclocycline 150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 228 through July 30, 2026
What is demeclocycline used for?
From the label: indications and usageDemeclocycline 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; […]
Conditions named in the indications of demeclocycline's FDA labels, with every medicine labeled for each:
From other demeclocycline labelsBacterial infections: INDICATIONS AND USAGE Demeclocycline hydrochloride tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below:
Urinary tract infections: Respiratory tract and urinary tract infections caused by Klebsiella species.
FDA pharmacologic class: Tetracycline-class Antimicrobial.
Source: FDA drug label (Demeclocycline Hydrochloride), Amneal Pharmaceuticals of New York LLC, effective April 2, 2026 (SPL set 539add06-e0a0-401a-b4f6-20776084aa9c), via openFDA; the full label on DailyMed
Is there a generic for demeclocycline (Declomycin)?
The FDA approved the first generic demeclocycline on March 22, 2004. 5 generic applications are approved; 3 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 demeclocycline from 5 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.
- 1960 earliest approval on file
- 2004 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for demeclocycline (Declomycin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.27 per Demeclocycline 150 mg tablet, down 30% from $3.25 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Demeclocycline 150 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Demeclocycline 150 mg tablet | Generic | $2.27 per tablet | $68.18 | -30% |
| Demeclocycline 300 mg tablet | Generic | $3.05 per tablet | $91.37 | -45% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the demeclocycline label say about other medicines?
The demeclocycline label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name demeclocycline. 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 |
|---|---|---|
| Tetracycline | warnings | IF ANY TETRACYCLINE IS USED DURING PREGNANCY, OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. |
Other labels that name demeclocycline
Source: FDA drug label (Demeclocycline Hydrochloride), Amneal Pharmaceuticals of New York LLC, effective April 2, 2026 (SPL set 539add06-e0a0-401a-b4f6-20776084aa9c), via openFDA; the full label on DailyMed
What do FAERS reports show for demeclocycline?
The FDA Adverse Event Reporting System holds 228 reports that list demeclocycline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 39 are coded as a death and 131 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.
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 demeclocycline?
26 other medicines are given the same way (oral) and in the same FDA class as demeclocycline or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 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 |
|---|---|---|---|---|
| Tetracycline | Bacterial infections | 10 labelers | $0.247 per capsule 250 mg capsule | No current entry |
| Doxycycline | Bacterial infections, Urinary tract infections | 71 labelers | $0.118 per tablet 100 mg tablet | A presentation being discontinued |
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
| Amoxicillin and clavulanate | Bacterial infections, Urinary tract infections | 31 labelers | $0.0693 per mL 600-42.9 mg/5 mL sus | No current entry |
| Azithromycin | Bacterial infections | 47 labelers | $0.266 per tablet 250 mg tablet | A presentation being discontinued |
| Cephalexin | Bacterial infections, Urinary tract infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Nitrofurantoin | Bacterial infections, Urinary tract infections | 47 labelers | $0.165 per capsule 50 mg capsule | A presentation being discontinued |
| Metronidazole | Bacterial infections | 40 labelers | $0.102 per tablet 250 mg tablet | In shortage |
Every medicine labeled for the same conditions as demeclocycline
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to demeclocycline
- 26 medicines for the same use
- Other tetracycline-class antimicrobials
- the pharmacologic class, with prices and generics
- Demeclocycline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other