HomeNDC LookupIngredientsDoxycycline Hyclate › 68047-0714-60
Doxycycline Hyclate 20 mg Tablet, 60-count — NDC 68047-0714-60 package photo

Doxycycline Hyclate 20 mg Tablet, 60-count

by Larken Laboratories, Inc. · 60 TABLET in 1 BOTTLE (68047-714-60)
NDC 68047-0714-60
🏷️ FDA NDC (as labeled) 68047-714-60 billing pads the product segment with a zero
This package
Contains60-count Cost per ea$0.0984 NADAC Per package$5.90 / 60 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $0.2300/unit — full pricing hub ↓
Also comes in: 100 tablets 68047-0714-01
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 →
⚠️
Other active recalls for Doxycycline Hyclate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 29, 2025 — Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. (Acella Pharmaceuticals, LLC) · FDA recall D-0014-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 68047-714-60
Product NDC 68047-714
11-digit billing NDC 68047071460
NCPDP billing unit EA — each (per item)
RxCUI 283535
UNII 19XTS3T51U
UPC 0368047714015, 0368047714602
Application # ANDA065287
SPL Set ID 49f82130-6f8a-412c-b625-e75906e74675
Established class (EPC) Tetracycline-class Drug
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-11-15
Route ORAL
Dosage form TABLET
Substance DOXYCYCLINE HYCLATE
GPI-14 04000020100302
GPI class Doxycycline Hyclate
GCN Seq No 048077
GCN 13521
HICL code 004013
Ingredient (HICL) Doxycycline Hyclate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D1
Therapeutic class — intermediate (HIC2) Dental Preparations
HIC3 code D1A
Therapeutic class — specific (HIC3) Periodontal Collagenase Inhibitors
AHFS code 52:04.04.00
AHFS class Antibacterials (52:04)
FDB label name DOXYCYCLINE HYCLATE 20 MG TAB
FDB brand name Doxycycline Hyclate
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 68047-714-60 — 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 → 68047-0714-60. 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 Drug class.

Pharmacologic class Tetracycline-class Drug
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, 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

LabelerLarken Laboratories, Inc.
Application holderPHARMOBEDIENT CONSULTING LLC
FDA applicationANDA065287 (ANDA)
Labeler code68047
First marketedNov 2010
Product typeHuman Prescription Drug
Portfolio12 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 DOXYCYCLINE HYCLATE 20 MG TAB Ingredient Doxycycline Hyclate
📖 What it is MedlinePlus · NLM

Doxycycline is used to treat infections caused by bacteria and certain other infections spread by ticks, lice, mites, and infected animals. Doxycyline is also used to prevent malaria and to treat acne and rosacea (a skin disease that causes redness, flushing, and pimples on the face) Doxycycline 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. It works to treat rosacea b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Doxycycline is quite versatile. It treats a wide range of bacterial infections — respiratory infections, STIs like chlamydia and gonorrhea, tick-borne illnesses like Rocky Mountain...
  • What kinds of infections does doxycycline actually treat?
  • It depends on the tablet strength your doctor prescribed. In general, if doxycycline bothers your stomach, taking it with food or milk can help — and for the 200 mg tablet specific...
  • Should I take doxycycline with food or on an empty stomach?
📖 Read our full Doxycycline guide →
7
Nutrient depletion considerations

Doxycycline Hyclate may be associated with lower levels of 7 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 yellow
ShapeRound
ImprintLL714
Size8 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 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.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

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

The official label also statesInactive ingredients in the formulation are: colloidal silicon dioxide, hypromellose, anhydrous lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide. Each tablet contains 23 mg of doxycycline hyclate equivalent to 20 mg of doxycycline.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.098 $5.90 / 60 tablets
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 $0.2300 $13.80 / 60 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.183 $0.094
▼ Down 36% over the last 24 months.
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
Doxycycline Hyclate 20 mg 42806-0362-01 EPIC 100 tablets $0.098 AB Availability likely
Doxycycline Hyclate 20 mg 53489-0647-01 Sun 100 tablets $0.098 AB Availability likely
Doxycycline Hyclate 20 mg 62135-0623-90 Chartwell 90 tablets $0.098 AB Availability likely
Doxycycline Hyclate 20 mg 62332-0352-31 Alembic 100 tablets $0.098 AB Availability likely
Doxycycline Hyclate 20 mgthis 68047-0714-60 Larken 60 tablets $0.098 AB Availability likely
Doxycycline Hyclate 20 mg 46708-0352-31 Alembic 100 tablets AB FDA listed
Doxycycline Hyclate 20 mg 71335-2526-01 Bryant 20 tablets AB FDA listed
Doxycycline Hyclate 20 mg 72162-2256-01 Bryant 100 tablets AB FDA listed
Doxycycline Hyclate 20 mg 72789-0309-01 PD-Rx 100 tablets 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

🏛️
2010
On the market since
Nov 2010
📍
2026
Currently FDA-listed
16 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Doxycycline Hyclate — the program that covers self-administered drugs. 29 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Doxycycline Hyclate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.44M
Claims incl. refills
1.9M
Beneficiaries
1.6M
Spend / beneficiary
$12.09
Spend / claim
$10.40
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
68047-0714-01 100 TABLET in 1 BOTTLE (68047-714-01) $0.0984 / ea $9.84 2010-11-15 Active
68047-0714-60 You're viewing this 60 TABLET in 1 BOTTLE (68047-714-60) $0.0984 / ea $5.90 2010-11-15 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0984 NADAC).

Pack size FAQ

What quantity is in NDC 68047-0714-60?
NDC 68047-0714-60 is a 60-count package — 60 tablet in 1 bottle.
What is the difference between NDC 68047-0714-60 and NDC 68047-0714-01?
Both are Doxycycline Hyclate 20 mg Tablet — the drug itself is identical. NDC 68047-0714-60 is the 60-count package, while NDC 68047-0714-01 is the 100 tablets package.
What NDC number is used to bill for this package of Doxycycline Hyclate 20 mg Tablet?
Bill NDC 68047-0714-60 — the 11-digit billing format is 68047071460. 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.

📄 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 32 words

INDICATIONS AND USAGE Doxycycline Hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

⏱️ Dosage and Administration 143 words

DOSAGE AND ADMINISTRATION THE DOSAGE OF DOXYCYCLINE HYCLATE DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS. Doxycycline hyclate 20 mg twice daily as an adjunct following scaling and root planing may be administered for up to 9 months.

Doxycycline hyclate should be taken twice daily at 12 hour intervals, usually in the morning and evening. It is recommended that if doxycycline hyclate is taken close to meal times, allow at least one hour prior to or two hours after meals. Safety beyond 12 months and efficacy beyond 9 months have not been established.

Administration of adequate amounts of fluid along with the tablets is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS section).

Contraindications 19 words

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

⚠️ Warnings ~2 min read

WARNINGS 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 has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.

TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP AND IN PREGNANT OR NURSING MOTHERS UNLESS THE POTENTIAL BENEFITS MAY BE ACCEPTABLE DESPITE THE POTENTIAL RISKS. 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 tetracyclines in doses of 25 mg/kg every 6 hours.

This reaction was shown to be reversible when the drug was discontinued. Doxycycline can cause fetal harm when administered to a pregnant woman. 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 any tetracyclines are used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. The catabolic action of the tetracyclines may cause an increase in BUN.

Previous studies have not observed an increase in BUN with the use of doxycycline in patients with impaired renal function. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

Fixed drug eruptions have occurred with doxycycline and have been associated with worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption (see Adverse Reactions for Tetracyclines). If severe skin reactions occur, discontinue Doxycycline Hyclate tablets immediately and institute appropriate therapy. Adverse Reactions for Tetracyclines: Skin: Maculopapular and erythematous rashes, and fixed drug eruption have been reported.

Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above (see WARNINGS section).

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS sdverse Reactions in Clinical Trials of a bioequivalent form of doxycycline hyclate capsules: In clinical trials of adult patients with periodontal disease 213 patients received 20 mg BID over a 9 - 12 month period. The most frequent adverse reactions occurring in studies involving treatment with a bioequivalent form of doxycycline hyclate capsules or placebo are listed below: Incidence (%) of Adverse Reactions in Clinical Trials of Doxycycline Hyclate Capsules, 20 mg(Bioequivalent to Doxycycline Hyclate Tablets, 20 mg) vs.

Placebo Adverse Reaction Doxycycline Hyclate Capsules 20 mg BID (n=213) Placebo (n=215) Note: Percentages are based on total number of study participants in each treatment group. Headache 55 (26%) 56 (26%) Common Cold 47 (22%) 46 (21%) Flu Symptoms 24 (11%) 40 (19%) Tooth Ache 14 (7%) 28 (13%) Periodontal Abscess 8 (4%) 21 (10%) Tooth Disorder 13 (6%) 19 (9%) Nausea 17 (8%) 12 (6%) Sinusitis 7 (3%) 18 (8%) Injury 11 (5%) 18 (8%) Dyspepsia 13 (6%) 5 (2%) Sore Throat 11 (5%) 13 (6%) Joint Pain 12 (6%) 8 (4%) Diarrhea 12 (6%) 8 (4%) Sinus Congestion 11 (5%) 11 (5%) Coughing 9 (4%) 11 (5%) Sinus Headache 8 (4%) 8 (4%) Rash 8 (4%) 6 (3%) Back Pain 7 (3%) 8 (4%) Back Ache 4 (2%) 9 (4%) Menstrual Cramp 9 (4%) 5 (2%) Acid Indigestion 8 (4%) 7 (3%) Pain 8 (4%) 5 (2%) Infection 4 (2%) 6 (3%) Gum Pain 1(<1%) 6 (3%) Bronchitis 7 (3%) 5 (2%) Muscle Pain 2 (1%) 6 (3%) Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region.

Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed.

(See DOSAGE AND ADMINISTRATION section). Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon.

Photosensitivity is discussed above. (See WARNINGS section). Renal toxicity: Rise in BUN has been reported and is apparently dose related.

(See WARNINGS section). Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

Psychiatric: Depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination. To report SUSPECTED ADVERSE REACTIONS, contact Larken Laboratories, Inc. at 1-601-855-7678 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🔄 Drug Interactions 116 words

Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacterial antibiotics, such as the tetracycline class of antibiotics, may interfere with the bactericidal action of members of the β-lactam (e.g. penicillin) class of antibiotics, it is not advisable to administer these antibiotics concomitantly. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron containing preparations, and by bismuth subsalicylate.

Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. Concurrent use of tetracyclines may render oral contraceptives less effective.

🔄 Drug / Laboratory Test Interactions 18 words

Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

🤰 Pregnancy 27 words

Pregnancy Teratogenic Effects: (See WARNINGS section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues. Nonteratogenic effects (See WARNINGS section).

🧒 Pediatric Use 16 words

Pediatric Use The use of doxycycline hyclate in infancy and childhood is contraindicated. (See WARNINGS section.)

🆘 Overdosage 31 words

OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY After oral administration, doxycycline hyclate is rapidly and nearly completely absorbed from the gastrointestinal tract. Doxycycline is eliminated with a half-life of approximately 18 hours by renal and fecal excretion of unchanged drug. Mechanism of Action: Doxycycline has been shown to inhibit collagenase activity in vitro .

1 Additional studies have shown that doxycycline reduces the elevated collagenase activity in the gingival crevicular fluid of patients with adult periodontitis. 2,3 The clinical significance of these findings is not known. Microbiology: Doxycycline is a member of the tetracycline class of antibiotics.

The dosage of doxycycline achieved with this product during administration is well below the concentration required to inhibit microorganisms commonly associated with adult periodontitis. Clinical studies with this product demonstrated no effect on total anaerobic and facultative bacteria in plaque samples from patients administered this dose regimen for 9 to 18 months. This product should not be used for reducing the numbers of or eliminating those microorganisms associated with periodontitis.

Pharmacokinetics The pharmacokinetics of doxycycline following oral administration of doxycycline hyclate were investigated in 4 volunteer studies involving 107 adults. Additionally, doxycycline pharmacokinetics have been characterized in numerous scientific publications. 4 Pharmacokinetic parameters for doxycycline hyclate following single oral doses and at steady-state in healthy subjects are presented as follows: Pharmacokinetic Parameters for Doxycycline Hyclate n C max Mean ± SD (ng/mL) T max Mean and range (hr) Cl/F (L/hr) t1/2 (hr) Single dose 20 mg (tablet) 20 362±101 1.4 (1.0-2.5) 3.85±1.3 18.1±4.85 Steady-State 20 mg BID Steady-State data were obtained from normal volunteers administered a bioequivalent formulation.

30 790±285 2 (0.98-12.0) 3.76±1.06 Not Determined Absorption: Doxycycline is well absorbed after oral administration. In a single-dose study, concomitant administration of doxycycline hyclate with a 1000 calorie, high-fat, high-protein meal which included dairy products, in healthy volunteers, resulted in a decrease in the rate and extent of absorption and delay in the time to maximum concentrations. Distribution: Doxycycline is greater than 90% bound to plasma proteins.

Its apparent volume of distribution is variously reported as between 52.6 and 134 L. 4,6 Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is variously reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. 5,6 Half-life averaged 18 hours in subjects receiving a single 20 mg doxycycline dose.

Special Populations Geriatric: Doxycycline pharmacokinetics have not been evaluated in geriatric patients. Pediatric: Doxycycline pharmacokinetics have not been evaluated in pediatric patients (See WARNINGS section). Gender: Doxycycline pharmacokinetics were compared in 9 men and 11 women under fed and fasted conditions.

While female subjects had a higher rate (C max ) and extent of absorption (AUC), these differences are thought to be due to differences in body weight/lean body mass. Differences in other pharmacokinetic parameters were not significant. Race: Differences in doxycycline pharmacokinetics among racial groups have not been evaluated.

Renal Insufficiency: Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function. Hemodialysis does not alter the half-life of doxycycline. Hepatic Insufficiency: Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency.

Drug Interactions: (See PRECAUTIONS section) Clinical Study In a randomized, mu…

🧬 Mechanism of Action 46 words

Mechanism of Action: Doxycycline has been shown to inhibit collagenase activity in vitro . 1 Additional studies have shown that doxycycline reduces the elevated collagenase activity in the gingival crevicular fluid of patients with adult periodontitis. 2,3 The clinical significance of these findings is not known.

📦 How Supplied / Storage and Handling 74 words

HOW SUPPLIED Doxycycline hyclate are white film coated, round, biconvex tablet, debossed LL714 on one side and plain on the other side containing doxycycline hyclate equivalent to 20 mg doxycycline. Bottle of 60 tablets (NDC 68047-714-60) and Bottle of 100 tablets (NDC 68047-714-01). Storage and Handling Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].

Dispense in tight, light-resistant containers (USP). Manufactured for: Larken Laboratories, Inc . Canton, MS 39046 www.larkenlabs.com 201095-01 Rev.

07/25

📦 Storage and Handling 31 words

Storage and Handling Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP). Manufactured for: Larken Laboratories, Inc . Canton, MS 39046 www.larkenlabs.com 201095-01 Rev. 07/25

🧪 Inactive Ingredients 43 words

Inactive Ingredients: Inactive ingredients in the formulation are: colloidal silicon dioxide, hypromellose, anhydrous lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide. Each tablet contains 23 mg of doxycycline hyclate equivalent to 20 mg of doxycycline.

📋 Description 96 words

DESCRIPTION Doxycycline hyclate is available as a 20 mg tablet formulation of doxycycline for oral administration. The structural formula of doxycycline hyclate is: with an empirical formula of (C 22 H 24 N 2 O 8 •HCl) 2 •C 2 H 6 O•H 2 O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a–octahydro-3, 5, 10, 12, 12a–octahydro-3, 5, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.

Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water. doxycycline-hyclate-molecular-structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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