HomeNDC LookupIngredientsTetracycline Hydrochloride › 51991-0906-33
Tetracycline Hydrochloride 250 mg Capsule, 30-count — NDC 51991-0906-33 package photo

Tetracycline Hydrochloride 250 mg Capsule, 30-count

by Breckenridge Pharmaceutical, Inc. · 30 CAPSULE in 1 BOTTLE, PLASTIC (51991-906-33)
NDC 51991-0906-33
🏷️ FDA NDC (as labeled) 51991-906-33 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $1.66/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 51991-906-33
Product NDC 51991-906
11-digit billing NDC 51991090633
RxCUI 198250, 198252
UNII P6R62377KV
UPC 0351991906018
Application # ANDA210662
SPL Set ID 00acf413-c5d2-4a54-9d0d-56266cbc9edc
Established class (EPC) Tetracycline-class Antimicrobial
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-01-18
Route ORAL
Dosage form CAPSULE
Substance TETRACYCLINE HYDROCHLORIDE
GPI-14 04000060100105
GPI class Tetracycline HCl
GCN Seq No 009189
GCN 40072
HICL code 004003
Ingredient (HICL) Tetracycline Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1C
Therapeutic class — specific (HIC3) Tetracycline Antibiotics
AHFS code 08:12.24.00
AHFS class Tetracycline Antibiotics
FDB label name TETRACYCLINE 250 MG CAPSULE
FDB brand name Tetracycline Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 51991-906-33 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 51991-0906-33. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Tetracycline-class Antimicrobial class.

Pharmacologic class Tetracycline-class Antimicrobial
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Tetracycline and derivatives, Tetracyclines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBreckenridge Pharmaceutical, Inc.
Application holderBRECKENRIDGE PHARMACEUTICAL INC
FDA applicationANDA210662 (ANDA)
Labeler code51991
First marketedJan 2019
Product typeHuman Prescription Drug
Portfolio71 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TETRACYCLINE 250 MG CAPSULE Ingredient Tetracycline Hcl
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Tetracycline guide →
11
Nutrient depletion considerations

Tetracycline may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Blue / Yellow
ShapeCapsule
ImprintB907
Size22 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    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.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    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.
  • 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.
  • 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.
  • 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.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII R4OXA9G5BV
    A fatty acid salt derived from palm and stearic oils. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking together.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • 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.
  • 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.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

17 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.66 $49.94 / 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tetracycline Hydrochloride 250 mg 00591-2474-01 Actavis 100 capsules $0.246 AB Discontinued
Tetracycline Hydrochloride 250 mg 23155-0766-01 Heritage 100 capsules $0.246 AB Availability likely
Tetracycline Hydrochloride 250 mg 60219-1522-01 Amneal 100 capsules $0.246 AB Availability likely
Tetracycline Hydrochloride 250 mg 62135-0225-01 Chartwell 100 capsules $0.246 AB Availability likely
Tetracycline Hydrochloride 250 mg 69238-1522-01 Amneal 100 capsules $0.246 AB Availability likely
tetracycline hydrochloride 250 mg 23155-0017-01 Heritage 100 capsules $0.769 AB FDA listed
Tetracycline Hydrochloride 250 mgthis 51991-0906-33 Breckenridge 30 capsules AB FDA listed
Tetracycline Hydrochloride 250 mg 71335-2415-01 Bryant 20 capsules AB FDA listed
Tetracycline Hydrochloride 250 mg 71335-3170-01 Bryant 20 capsules AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 capsules51991-0906-01 965 Rx · $48,765
500 capsules51991-0906-05 No Medicaid data
Drug total (last 4 qtrs): 965 Rx · 67,340 units · $48,765 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
51991-0906-01 100 CAPSULE in 1 BOTTLE, PLASTIC (51991-906-01) $0.2462 / ea $24.62 2019-01-18 Active
51991-0906-05 500 CAPSULE in 1 BOTTLE, PLASTIC (51991-906-05) 2019-01-18 Active
51991-0906-33 You're viewing this 30 CAPSULE in 1 BOTTLE, PLASTIC (51991-906-33) 2019-01-18 Active

You're viewing the smallest of 3 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 100 capsules pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 51991-0906-33?
NDC 51991-0906-33 is a 30-count package — 30 capsule in 1 bottle, plastic.
What is the difference between NDC 51991-0906-33 and NDC 51991-0906-01?
Both are Tetracycline Hydrochloride 250 mg Capsule — the drug itself is identical. NDC 51991-0906-33 is the 30-count package, while NDC 51991-0906-01 is the 100 capsules package.
What NDC number is used to bill for this package of Tetracycline Hydrochloride 250 mg Capsule?
Bill NDC 51991-0906-33 — the 11-digit billing format is 51991090633. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51991-906-33, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51991-0906-33, written without dashes as 51991090633. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51991-0906-33, the first segment (51991) is the labeler code FDA assigned to Breckenridge Pharmaceutical, Inc.; the middle segment (0906) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (33) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Breckenridge Pharmaceutical, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 100 capsules (51991-0906-01), 500 capsules (51991-0906-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Breckenridge Pharmaceutical, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~2 min read

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 ~2 min read

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 (25mg/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 Chlamydiatrachomatis: 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 16 words

CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

⚠️ Warnings ~3 min read

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.

Fixed Drug Eruption Fixed drug eruptions have occurred with tetracycline and have been associated with worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption (see ADVERSE REACTIONS ). If severe skin reactions occur, discontinue tetracycline hydrochloride capsules immediately and institute appropriate therapy. Intracranial Hypertension Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Achromycin V.

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 resolves 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 dr…

🤒 Adverse Reactions ~1 min read

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 : fixed drug eruption, maculopapular and erythematous 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088 or contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395.

🔄 Drug Interactions 83 words

Drug Interactions Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin or other bactericidal antibacterials. Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc, or sodium bicarbonate.

Concurrent use of tetracycline may render oral contraceptives less effective.

🤰 Pregnancy 28 words

Pregnancy Teratogenic Effects Pregnancy Category D (see WARNINGS ) Nonteratogenic Effects (see WARNINGS ) Pregnant women with renal disease may be more prone to develop tetracycline-associated liver failure.

🧒 Pediatric Use 9 words

Pediatric Use See WARNINGS and DOSAGE AND ADMINISTRATION .

🆘 Overdosage 17 words

OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracycline is not dialyzable.

🧬 Clinical Pharmacology ~1 min read

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 126 words

HOW SUPPLIED Tetracycline Hydrochloride Capsules, USP are available as: 250 mg: Blue opaque cap and yellow opaque Body, size '2', cap and body imprinted B906 in black ink. Available in bottles of: Bottle of 30 Count – NDC 51991-906-33 Bottle of 100 Count – NDC 51991-906-01 Bottle of 500 Count – NDC 51991-906-05 500 mg: Blue opaque cap and Blue opaque Body, size '0', cap and body imprinted B907 in black ink. Available in bottles of: Bottle of 30 Count – NDC 51991-907-33 Bottle of 100 Count – NDC 51991-907-01 Bottle of 500 Count – NDC 51991-907-05 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].

📦 Storage and Handling 13 words

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

📋 Description 182 words

DESCRIPTION Tetracycline is a yellow, 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: C 22 H 24 N 2 O 8 ∙ HCl M.W.480.90 Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride.

Inactive Ingredients : Lactose Monohydrate, Colloidal silicon dioxide, and magnesium stearate. The 250 mg capsule shells contain Gelatin, FD & C Blue 1, Titanium Dioxide, D & C Yellow 10, and FD & C Yellow 6. The 500 mg capsule shells contain Gelatin, FD&C Blue #1, and Titanium Dioxide.

The imprinting ink for the 250 mg and 500 mg capsules contains Shellac, Propylene Glycol, Black Iron Oxide, Potassium Hydroxide and Purified water. Chemical Structure

💬 Information for Patients 104 words

Information for Patients Counsel patients that antibacterial drugs including tetracycline should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When tetracycline is prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by tetracycline or other antibacterial drugs in the future.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.