Tetracycline Hydrochloride 500 mg Capsule, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Tetracycline-class Antimicrobial class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Tetracycline is used to treat infections caused by bacteria and certain other infections spread by ticks, lice, mites, and infected animals. It is also used to treat acne.Tetracycline is in a class of medications called tetracycline antibiotics. It works to treat infections by stopping bacteria from growing and spreading. It works to treat acne by killing the bacteria that infects pores and by lowering the amount of oil on your skin that can cause acne. Antibiotics such as tetracycline will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increase...
Read the full MedlinePlus article ↗- It's a fair frustration — food, dairy products, and even some common supplements like calcium, iron, or zinc can significantly reduce how much tetracycline your body actually absor...
- Why do I have to take tetracycline on an empty stomach? Can't I just take it with food to settle my stomach?
- This is actually an important one to sort out. Antacids containing aluminum, calcium, or magnesium can significantly block tetracycline from being absorbed properly, which means th...
- I was prescribed tetracycline but I also take a daily antacid for heartburn. Is that okay?
Patient education
Supplement & herbal interactions
Tetracycline may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
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A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.572 | $57.21 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.9050 | $90.50 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $1.66 | $166.47 / 100 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tetracycline Hydrochloride 500 mg 00591-2475-01 | Actavis | 100 capsules | $0.572 | — | Discontinued | — |
| Tetracycline Hydrochloride 500 mgthis 23155-0767-01 | Heritage | 100 capsules | $0.572 | AB | Availability likely | — |
| Tetracycline Hydrochloride 500 mg 51991-0907-01 | Breckenridge | 100 capsules | $0.572 | AB | Availability likely | — |
| Tetracycline Hydrochloride 500 mg 60219-1523-01 | Amneal | 100 capsules | $0.572 | AB | Availability likely | — |
| Tetracycline Hydrochloride 500 mg 62135-0266-01 | Chartwell | 100 capsules | $0.572 | AB | Availability likely | — |
| Tetracycline Hydrochloride 500 mg 69238-1523-01 | Amneal | 100 capsules | $0.572 | AB | Availability likely | — |
| tetracycline hydrochloride 500 mg 23155-0018-01 | Heritage | 100 capsules | $1.077 | AB | FDA listed | +88% |
| Tetracycline Hydrochloride 500 mg 68788-4134-03 | Preferred | 30 capsules | — | AB | FDA listed | — |
| Tetracycline Hydrochloride 500 mg 68788-8853-03 | Preferred | 30 capsules | — | AB | FDA listed | — |
| Tetracycline Hydrochloride 500 mg 71335-2141-01 | Bryant | 60 capsules | — | AB | FDA listed | — |
| Tetracycline Hydrochloride 500 mg 71335-2427-01 | Bryant | 60 capsules | — | AB | FDA listed | — |
| Tetracycline Hydrochloride 500 mg 82804-0292-56 | Proficient | 56 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 23155-0767-01 You're viewing this | 100 CAPSULE in 1 BOTTLE (23155-767-01) | 2020-04-01 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE To 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.
Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae . Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. Lower respiratory tract infections caused by Streptococcus pyogenes , Streptococcus pneumoniae , Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp. ) Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus .
(Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.) Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox. Psittacosis caused by Chlamydophila psittaci . Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum.
Granuloma inquinale caused by Klebsiella granulomatis . Relapsing fever caused by Borrelia sp . Bartonellosis caused by Bartonella bacilliformis .
Chancroid caused by Hemophilus ducreyi . Tularemia caused by Francisella tularensis . Plaque caused by Yersinia pestis .
Cholera caused by Vibrio cholerae . Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside). Infections due to Campylobacter fetus .
As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica . Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella , etc. Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp .
In severe acne, adjunctive therapy with tetracycline may be useful. When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections: Syphilis and yaws caused by Treponema pallidum and pertenue , respectively, Vincent’s infection caused by Fusobacterium fusiforme , Infections caused by Neisseria gonorrhoeae , Anthrax caused by Bacillus anthracis , Infections due to Listeria monocytogenes , Actinomycosis caused by Actinomyces species, Infections due to Clostridium species.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Adults: Usual daily dose, 1 gram as 500 mg twice a day or 250 mg four times a day. Higher doses such as 500 mg four times a day may be required for severe infections or for those infections which do not respond to the smaller doses. For pediatric patients above eight years of age: Usual daily dose, 10 mg/lb to 20 mg/lb (25 mg/kg to 50 mg/kg) body weight divided in four equal doses.
Administration of adequate amounts of fluid with the capsule formulation of tetracycline is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS ). Absorption of tetracycline is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc or sodium bicarbonate. Food and some dairy products also interfere with absorption.
When used in streptococcal infections, therapy should be continued for 10 days. For treatment of brucellosis, 500 mg tetracycline four times a day for three weeks accompanied by streptomycin, 1 gram intramuscularly twice daily the first week and once daily the second week. For the treatment of syphilis in patients allergic to penicillin, the following dosage of tetracycline is recommended: early syphilis (less than one year’s duration), 500 mg four times a day for 15 days.
Syphilis of more than one year’s duration (except neurosyphilis), 500 mg four times a day for 30 days. For treatment of gonorrhea, the recommended dose is 500 mg by mouth four times a day for seven days. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis : 500 mg, by mouth, four times a day for at least seven days.
In cases of moderate to severe acne which, in the judgement of the clinician, require long-term treatment, the recommended initial dosage is 1 gram daily in divided doses. When improvement is noted, reduce dosage gradually to maintenance levels ranging from 125 mg to 500 mg daily. In some patients it may be possible to maintain adequate remission of lesions with alternate day or intermittent therapy.
Tetracycline therapy of acne should augment the other standard measures known to be of value. Duration of long-term treatment which can safely be recommended has not been established (see WARNINGS and Carcinogenesis, Mutagenesis, Impairment of Fertility ). Use in Specific Population In patients with renal impairment (see WARNINGS ): decrease total dosage by reduction of recommended individual doses and/or by extending time intervals between doses.
⛔ Contraindications ▾
CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
⚠️ Warnings ▾
WARNINGS Tooth Development The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.
Tetracycline drugs should not be used in this age group, except for anthrax, unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including tetracyclines, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drugs.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing use of antibacterial drugs not directed against C. difficile need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and institute surgical evaluation clinically indicated.
Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Advise patients apt to be exposed to direct sunlight or ultraviolet lights that this reaction can occur with tetracycline drugs. Discontinue treatment at the first evidence of skin erythema.
Intracranial Hypertension Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Tetracycline. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH.
Concomitant use of isotretinoin and tetracycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri. Although IH typically resolve after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted.
Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize. Skeletal Development All tetracyclines form a stable calcium complex in any bone forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every six hours.
This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.
If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. Tetracycline drugs should not be used during pregnancy unless absolutely necessary. Antianabolic Action The antianabolic action of the tetracyclines may cause an increase in BUN.
While this is not a problem in those with normal renal function, in patients with significantly impaired renal functio…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Gastrointestinal: anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with Candida overgrowth) in the anogenital region. Esophagitis and esophageal ulceration have been reported in patients receiving particularly the capsule and also the tablet forms of tetracyclines. Most of the patients were reported to have taken medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ).
Teeth: permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has been reported (see WARNINGS ). Skin: maculopapular and erythrematous rashes.
Exfoliative dermatitis has been reported. Onycholysis and discoloration of the nails have been reported. Photosensitivity is discussed in WARNINGS .
Renal Toxicity: an increase in BUN has been reported and is dose related. Liver: hepatotoxicity and liver failure have been observed in patients receiving tetracycline and in tetracycline-treated patients with renal impairment. Hypersensitivity Reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, and serum sickness-like reactions, as fever, rash, and arthralgia.
Blood: hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia have been reported. When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur.
To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracycline is not dialyzable.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Tetracyclines are readily absorbed and are bound to plasma protein in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Microbiology Tetracyclines are primarily bacteriostatic and exert their antimicrobial effect by the inhibition of protein synthesis by binding to the 30S ribosomal subunit.
Tetracycline is active against a broad range of gram-negative and gram-positive organisms. The drugs in the tetracycline class have closely similar antimicrobial spectra, and cross-resistance among them is common. Tetracycline has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the package insert.
Gram-negative Bacteria Acinetobacter species Bartonella bacilliformis Brucella species Campylobacter fetus Enterobacter aerogenes Escherichia coli Francisella tularensis Haemophilus ducreyi Haemophilus influenzae Klebsiella species Klebsiella granulomatis Neisseria gonorrhoeae Shigella species Vibrio cholerae Yersinia pestis Gram-positive Bacteria Bacillus anthracis Streptococcus pyogenes Streptococcus pneumoniae Staphylococcus aureus Listeria monocytogenes Anaerobes Bacteroides species Clostridium species Fusobacterium fusiforme Propionibacterium acnes Other Bacteria Actinomyces species Borrelia recurrentis Chlamydophila psittaci Chlamydia trachomatis Rickettsiae Treponema pallidum Treponema pallidum subspecies pertenue Parasites Entamoeba species Balantidium coli Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Tetracycline Hydrochloride Capsules, USP are available as: 250 mg: Yellow Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted 5225 in Black Ink. Available in bottles of: 100 capsules - NDC 23155-766-01 500 mg: Orange Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted 5266 in Black Ink. Available in bottles of: 100 capsules - NDC 23155-767-01 Dispense in a tight, light-resistant container as defined in the USP.
Use child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
📋 Description ▾
DESCRIPTION Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions.
Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino) -1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows: Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride.
Inactive Ingredients: Lactose, and magnesium stearate. The 250 mg and 500 mg capsule shells contain D&C Yellow No. 10, FD&C Yellow No.
6, gelatin, sodium lauryl sulfate, and titanium dioxide. The imprinting ink for the 250 mg and 500 mg capsules contains D&C Yellow No. 10, FD&C Blue No.
1, FD&C Blue No. 2, FD&C Red No. 40, iron oxide black, pharmaceutical shellac glaze, propylene glycol, n-butyl alcohol, and ferrosoferric oxide.
This product complies with USP dissolution Test 2. structural-formula