Prescription and over-the-counter medicine
Tetracycline First approved as Achromycin
Tetracycline (Achromycin) is a prescription and over-the-counter medicine with an FDA approval on record since 1953. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.247 per tetracycline 250 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the tetracycline FDA label on DailyMed (effective March 18, 2025, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the NDA 50273 record on Drugs@FDA; every tetracycline label on DailyMed.
Highlights of the record
FDA label of March 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
Forms and strengths
- 250 mg
- 500 mg
Capsule; film-coated tablet.
On the market
- Earliest approval on file
- November 19, 1953 Achromycin, Lederle; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first September 17, 1954; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 10 under generic applications, 1 under brand applications, repackagers included; 4 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.247 per capsule Tetracycline 250 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2014 2 Class I among all firms' recalls; latest March 23, 2020; 1 more by firms not listed as its makers
- FAERS reports
- 767 through July 30, 2026
What is tetracycline used for?
From the label: indications and usageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. […]
Conditions named in the indications of tetracycline's FDA labels, with every medicine labeled for each:
From other tetracycline labelsBacterial infections: Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
FDA pharmacologic class: Tetracycline-class Antimicrobial.
Source: FDA drug label (tetracycline hydrochloride), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective March 18, 2025 (SPL set eaa5b1bd-0927-46e4-b941-32fcc492d258), via openFDA; the full label on DailyMed
Is there a generic for tetracycline (Achromycin)?
The FDA approved the first generic tetracycline on September 17, 1954. 27 generic applications are approved; 6 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 tetracycline from 10 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1953 earliest approval on file
- 1954 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tetracycline (Achromycin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.247 per Tetracycline 250 mg capsule, down 65% from $0.702 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.
- Tetracycline 250 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tetracycline 250 mg capsule | Generic | $0.247 per capsule | $7.42 | -65% |
| Tetracycline 500 mg capsule | Generic | $0.627 per capsule | $18.80 | -13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tetracycline been recalled?
The FDA's Enforcement Report lists 3 recalls naming tetracycline since 2014: 2 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of tetracycline 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 |
|---|---|---|---|
| March 23, 2020 | Class I | Avet Pharmaceuticals, Inc. | Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules. |
| August 27, 2014 | Class II | Martin Avenue Pharmacy, Inc. not a listed maker | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tetracycline label say about other medicines?
The tetracycline label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 28 other medicines name tetracycline. 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 |
|---|---|---|
| Isotretinoin | warnings | Concomitant use of isotretinoin and tetracycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri. |
| Sodium bicarbonate | drug interactions | Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc, or sodium bicarbonate. |
Other labels that name tetracycline
- Acetyl l-tyrosine, alanine and 15 other ingredients
- Aminophylline
- Anhydrous citric acid and magnesium oxide and sodium picosulfate
- Atovaquone
- Cholestyramine
- Colestipol
- Dicloxacillin
- Doxycycline
- Eravacycline
- Magnesium sulfate and potassium chloride and sodium sulfate
- Magnesium sulfate and potassium sulfate and sodium sulfate
- Magnesium sulfate, polyethylene glycol 3350 and 3 other ingredients
- Methotrexate
- Nafcillin
- Omadacycline
- Oxacillin
- Penicillin g benzathine
- Sucralfate
- Tigecycline
Source: FDA drug label (tetracycline hydrochloride), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective March 18, 2025 (SPL set eaa5b1bd-0927-46e4-b941-32fcc492d258), via openFDA; the full label on DailyMed
What do FAERS reports show for tetracycline?
The FDA Adverse Event Reporting System holds 767 reports that list tetracycline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 208 are coded as a death and 286 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 tetracycline?
23 other medicines are given the same way (oral) and in the same FDA class as tetracycline 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 |
|---|---|---|---|---|
| Demeclocycline | Bacterial infections | 5 labelers | $2.27 per tablet 150 mg tablet | No current entry |
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
| Azithromycin | Bacterial infections | 47 labelers | $0.266 per tablet 250 mg tablet | A presentation being discontinued |
| Cephalexin | Bacterial infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Metronidazole | Bacterial infections | 40 labelers | $0.102 per tablet 250 mg tablet | In shortage |
| Clindamycin | Bacterial infections | 40 labelers | $0.103 per capsule 150 mg capsule | In shortage |
| Sulfamethoxazole and trimethoprim | Bacterial infections | 42 labelers | $0.0448 per tablet Sulfamethoxazole-tmp ds tablet | No current entry |
| Levofloxacin | Bacterial infections | 35 labelers | $0.259 per tablet 750 mg tablet | No current entry |
Every medicine labeled for the same conditions as tetracycline
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tetracycline compare with medicines for the same use?
10 side-by-side pages set tetracycline beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tetracycline
- 23 medicines for the same use
- Other tetracycline-class antimicrobials
- the pharmacologic class, with prices and generics
- Tetracycline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other