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Doxycycline Hyclate 100 mg Capsule, 14-count — NDC 49999-0126-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Doxycycline Hyclate 100 mg Capsule, 14-count — NDC 49999-126-14 (Billing 49999-0126-14)

by Quality Care Products, LLC · 14 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 14 capsules of Doxycycline Hyclate 100 mg Capsule from Quality Care Products, LLC, marketed since Apr 2012 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 49999-0126-14
🏷️ FDA NDC (as labeled) 49999-126-14 billing pads the product segment with a zero
This package
Contains14-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2471/unit — full pricing hub ↓
Main listing for product 49999-126 · Also comes in: 20 capsules 49999-126-20 30 capsules 49999-126-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49999-126-14
Product NDC 49999-126
11-digit billing NDC 49999012614
NCPDP billing unit EA — each (per item)
RxCUI 1649988
UNII 19XTS3T51U
Application # ANDA062676
SPL Set ID 2a3b79e8-f14c-4b44-9d3e-3c92a82269bd
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 2012-04-16
Marketing end 2027-05-31
Route ORAL
Dosage form CAPSULE
Substance DOXYCYCLINE HYCLATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 04000020100110
GPI class Doxycycline Hyclate
GCN Seq No 009218
GCN 40331
HICL code 004013
Ingredient (HICL) Doxycycline Hyclate
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 DOXYCYCLINE HYCLATE 100 MG CAP
FDB brand name Doxycycline Hyclate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009218
  • GCN: 40331
  • GPI-14 (Medi-Span): 04000020100110
  • HICL (First Databank): 004013
  • AHFS class code: 08:12.24.00
  • RxCUI (RxNorm): 1649988
Why two NDCs? The FDA registers this code as 49999-126-14 — 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 → 49999-0126-14. 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.

Clinical

Label name DOXYCYCLINE HYCLATE 100 MG CAP 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
  • It is an antibiotic for bacterial infections such as rickettsial infections, sexually transmitted infections, respiratory tract infections and eye infections. Some products are als...
  • Take it exactly as your prescriber and label say. Swallow capsules with a full glass of water and avoid taking them right before lying down. For one capsule product, take it at lea...
  • Diarrhea, nausea, vomiting, stomach upset and loss of appetite are the most common. You may also sunburn much more easily, so cover up and avoid tanning beds. Call me or your docto...
  • Call right away for severe or watery diarrhea, a blistering or peeling rash, headache with vision changes, trouble swallowing, or signs of an allergic reaction. Diarrhea can show u...
📖 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.

🧪 Full Doxycycline Hyclate nutrient depletion report →
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.

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 $0.2471 $3.46 / 14 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49999-0126-30 49999-126-30 30 CAPSULE in 1 BOTTLE, PLASTIC 2012-04-16 — Active
49999-0126-14 You're viewing this Main listing 14 CAPSULE in 1 BOTTLE, PLASTIC 2012-04-16 — Active
49999-0126-20 49999-126-20 20 CAPSULE in 1 BOTTLE, PLASTIC 2012-04-16 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 14-count package — 14 capsule in 1 bottle, plastic.
How does this package differ from NDC 49999-0126-20?
Both are Doxycycline Hyclate 100 mg Capsule — the drug itself is identical. This page's package is the 14-count one, while NDC 49999-0126-20 is the 20 capsules package.
What NDC number is used to bill for this package of Doxycycline Hyclate 100 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxycycline Hyclate 100 mg 00143-9803-05 Hikma 500 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 00904-0428-04 Major 30 capsules $0.105 AB Availability likely —
doxycycline 100 mg 27808-0233-01 Cranbury 50 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 50268-0278-15 AvPAK 50 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 53489-0119-02 Sun 50 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 60687-0513-65 American 50 capsules $0.105 AB Availability likely —
doxycycline hyclate 100 mg 62332-0363-50 Alembic 50 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 69238-1100-02 Amneal 50 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 27241-0141-08 Ajanta 500 capsules — — FDA listed —
Doxycycline Hyclate 100 mg 33342-0386-08 Macleods 50 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 43063-0988-20 PD-Rx 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 43063-0999-06 PD-Rx 6 capsules — AB FDA listed —
doxycycline hyclate 100 mg 46708-0363-50 Alembic 50 capsules — AB FDA listed —
Doxycycline Hyclate 100 mgthis 49999-0126-14 Quality 14 capsules — AB FDA listed —
doxycycline hyclate 100 mg 50090-5560-01 A-S 20 capsules — AB FDA listed —
doxycycline hyclate 100 mg 50090-5588-00 A-S 20 capsules — AB FDA listed —
doxycycline 100 mg 50090-7410-01 A-S 14 capsules — AB FDA listed —
doxycycline 100 mg 50090-7411-01 A-S 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 51655-0478-20 Northwind 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 60219-1100-01 Amneal 100 capsules — AB FDA listed —
doxycycline 100 mg 60760-0721-20 ST. 20 capsules — AB Discontinued —
Doxycycline Hyclate 100 mg 61919-0082-20 DIRECT 20 capsules — AB FDA listed —
doxycycline hyclate 100 mg 62135-0985-01 Chartwell 100 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 67046-0135-03 Coupler 30 capsules — AB FDA listed —
doxycycline 100 mg 68071-2761-02 NuCare 2 capsules — AB Discontinued —
Doxycycline Hyclate 100 mg 68071-4883-04 NuCare 4 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-4950-02 NuCare 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-5232-04 NuCare 4 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-5259-02 NuCare 20 capsules — AB FDA listed —
doxycycline 100 mg 68788-8588-01 Preferred 14 capsules — AB FDA listed —
doxycycline hyclate 100 mg 68999-0985-05 Chartwell 500 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 69434-0017-03 Zhejiang 500 capsules — — FDA listed —
Doxycycline Hyclate 100 mg 70518-1248-00 REMEDYREPACK 14 capsules — AB FDA listed —
Doxycyclate Hyclate 100 mg 70518-1627-00 REMEDYREPACK 30 capsules — AB FDA listed —
doxycycline 100 mg 70518-3488-00 REMEDYREPACK 20 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 70518-4150-00 REMEDYREPACK 14 capsules — AB FDA listed —
doxycycline 100 mg 70518-4655-00 REMEDYREPACK 10 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-4658-00 REMEDYREPACK 6 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 70771-1359-00 Zydus 1000 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 71205-0385-14 Proficient 14 capsules — AB FDA listed —
doxycycline hyclate 100 mg 71205-0518-02 Proficient 2 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-0861-00 Bryant 6 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-1464-00 Bryant 6 capsules — AB FDA listed —
doxycycline hyclate 100 mg 71335-1549-00 Bryant 6 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 71335-2086-00 Bryant 6 capsules — AB FDA listed —
doxycycline 100 mg 71335-2100-00 Bryant 6 capsules — AB FDA listed —
Doxycycline 100 mg 72189-0006-20 Direct_Rx 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 72189-0559-20 Diirect_rx 20 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 72578-0055-01 Viona 100 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0277-20 PD-Rx 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0298-20 PD-Rx 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0369-02 PD-Rx 2 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 76420-0044-10 Asclemed 10 capsules — AB FDA listed —
doxycycline 100 mg 76420-0562-10 Asclemed 10 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 76420-0813-00 Asclemed 1000 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 80425-0114-02 Advanced 30 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 80425-0211-01 Advanced 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 80425-0280-01 Advanced 10 capsules — AB FDA listed —
doxycycline 100 mg 82804-0046-06 Proficient 6 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 82804-0179-14 Proficient 14 capsules — AB FDA listed —
Doxycycline 100 mg 83112-0233-28 Health 28 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 83112-0985-05 Health 1 capsule — AB FDA listed —
Doxycycline hyclate 100 mg 85766-0033-00 Sportpharm 1000 capsules — AB FDA listed —
doxycycline hyclate 100 mg 85766-0052-01 Sportpharm 100 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 87441-0029-01 Unit 30 capsules — AB FDA listed —
doxycycline hyclate 100 mg 85534-0048-00 HAWAII 10 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

🏛️
2012
On the market since
Apr 2012
📍
2026
Currently FDA-listed
14 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.

What it looks like

Color Blue
ShapeCapsule
ImprintMutual;105
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 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • 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 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 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 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.

8 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 DailyMed — 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?
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.

Manufacturer & labeler

LabelerQuality Care Products, LLC
Application holderSUN PHARMACEUTICAL INDUSTRIES INC
FDA applicationANDA062676 (ANDA)
Labeler code49999
First marketedApr 2012
Product typeHuman Prescription Drug
Portfolio70 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.

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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent 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.

Treatment: Doxycycline is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae . Lymphogranuloma venereum caused by Chlamydia trachomatis .

Psittacosis (ornithosis) caused by Chlamydia psittaci . Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis .

Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis . Nongonococcal urethritis caused by Ureaplasma urealyticum . Relapsing fever due to Borrelia recurrentis .

Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Chancroid caused by Haemophilus ducreyi . Plague due to Yersinia pestis (formerly Pasteurella pestis ). Tularemia due to Francisella tularensis (formerly Pasteurella tularensis ).

Cholera caused by Vibrio cholerae (formerly Vibrio comma ). Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus ). Brucellosis due to Brucella species (in conjunction with streptomycin).

Bartonellosis due to Bartonella bacilliformis . Granuloma inguinale caused by Calymmatobacterium granulomatis . Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.

Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Enterobacter aerogenes (formerly Aerobacter aerogenes ). Shigella species.

Acinetobacter species (formerly Mima species and Herellea species). Respiratory tract infections caused by Haemophilus influenzae . Respiratory tract and urinary tract infections caused by Klebsiella species.

Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae ). Anthrax due to Bacillus anthracis , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis . When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae .

Syphilis caused by Treponema pallidum . Yaws caused by Treponema pertenue . Listeriosis due to Listeria monocytogenes .

Vincent's infection caused by Fusobacterium fusiforme . Actinomycosis caused by Actinomyces israelii . Infections caused by Clostridium species.

In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains.

(See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS sec…

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.

In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended. For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections, up to 2 mg/lb of body weight may be used.

For children over 100 lb the usual adult dose should be used. The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. When used in streptococcal infections, therapy should be continued for 10 days.

Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS .) If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.

Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment. Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.

The dose may be administered with food, including milk or carbonated beverage, as required. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth, twice a day for 7 days. Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum : 100 mg, by mouth, twice a day for 7 days.

Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks. Syphilis of more than one year's duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks. Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.

Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days. For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose.

Prophylaxis should begin 1–2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area. Inhalational anthrax (post-exposure): ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.

CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the 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 it 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, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline hyclate, 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 antibiotic use.

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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 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 any tetracycline is 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 antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur 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.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Due to oral doxycycline's virtually complete absorption, side effects of the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported rarely.

These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed.

(See DOSAGE AND ADMINISTRATION .) Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above.

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

Other: bulging fontanels in infants and intracranial hypertension in adults. (See PRECAUTIONS – General .) When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. No abnormalities of thyroid function studies are known to occur.

🔄 Drug Interactions 108 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 bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

Absorption of tetracyclines is impaired by bismuth subsalicylate. Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. The concurrent use of tetracycline and Penthrane ® (methoxyflurane) has been reported to result in fatal renal toxicity.

Concurrent use of tetracycline 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 ~1 min read ▾

Pregnancy: Teratogenic Effects. Pregnancy Category D: There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. The vast majority of reported experience with doxycycline during human pregnancy is short-term, first trimester exposure.

There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women, such as that proposed for treatment of anthrax exposure. An expert review of published data on experiences with doxycycline use during pregnancy by TERIS – the Teratogen Information System – concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and quality of data were assessed as limited to fair), but the data are insufficient to state that there is no risk a .

A case-control study (18,515 mothers of infants with congenital anomalies and 32,804 mothers of infants with no congenital anomalies) shows a weak but marginally statistically significant association with total malformations and use of doxycycline anytime during pregnancy. Sixty-three (0.19%) of the controls and fifty-six (0.30%) of the cases were treated with doxycycline. This association was not seen when the analysis was confined to maternal treatment during the period of organogenesis (i.e., in the second and third months of gestation) with the exception of a marginal relationship with neural tube defect based on only two exposed cases b .

A small prospective study of 81 pregnancies describes 43 pregnant women treated for 10 days with doxycycline during early first trimester. All mothers reported their exposed infants were normal at 1 year of age c . Nonteratogenic Effects: (See WARNINGS .)

🧒 Pediatric Use 9 words ▾

Pediatric Use See WARNINGS and DOSAGE AND ADMINISTRATION .

🆘 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 overdosage.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are concentrated by the liver in the bile, and excreted in the urine and feces at high concentrations and in a biologically active form. Doxycycline is virtually completely absorbed after oral administration.

Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of doxycycline at 2 hours, decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min.). This percentage excretion may fall as low as 1–5%/72 hours in individuals with severe renal insufficiency (creatinine clearance below 10 mL/min.).

Studies have shown no significant difference in serum half-life of doxycycline (range 18–22 hours) in individuals with normal and severely impaired renal function. Hemodialysis does not alter serum half-life. Results of animal studies indicate that tetracyclines cross the placenta and are found in fetal tissues.

Microbiology The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including doxycycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracyclines is common.

Gram-Negative Bacteria Neisseria gonorrhoeae Calymmatobacterium granulomatis Haemophilus ducreyi Haemophilus influenzae Yersinia pestis (formerly Pasteurella pestis ) Francisella tularensis (formerly Pasteurella tularensis ) Vibrio cholerae (formerly Vibrio comma ) Bartonella bacilliformis Brucella species Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended: Escherichia coli Klebsiella species Enterobacter aerogenes Shigella species Acinetobacter species (formerly Mima species and Herellea species) Bacteroides species Gram-Positive Bacteria Because many strains of the following groups of gram-positive microorganisms have been shown to be resistant to tetracycline, culture and susceptibility testing are recommended.

Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. Streptococcus pyogenes Streptococcus pneumoniae Enterococcus group ( Streptococcus faecalis and Streptococcus faecium ) Alpha-hemolytic streptococci (viridans group) Other Microorganisms Rickettsiae Chlamydia psittaci Chlamydia trachomatis Mycoplasma pneumoniae Ureaplasma urealyticum Borrelia recurrentis Treponema pallidum Treponema pertenue Clostridium species Fusobacterium fusiforme Actinomyces species Bacillus anthracis Propionibacterium acnes Entamoeba species Balantidium coli Plasmodium falciparum Doxycycline has been found to be active against the asexual erythrocytic forms of Plasmodium falciparum, but not against the gametocytes of P. falciparum .

The precise mechanism of action of the drug is not known. Susceptibility tests: Diffusion techniques: Quantitative methods that require measurement of zone diameters give the most precise estimate of the susceptibility of bacteria to antimicrobial agents. One such standard procedure 1 which has been recommended for use with disks to test susceptibility of organisms to doxycycline uses the 30-mcg tetracycline-class disk or the 30-mcg doxycycline disk.

Interpretation involves the correlation of the diameter obtained in the disk test with the minimum inhibitory concentration (MIC) for tetracycline or doxycycline, respectively. Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30-mcg tetracycline-cl…

📦 How Supplied / Storage and Handling 126 words ▾

HOW SUPPLIED: Doxycycline hyclate capsules and tablets are available as follows: a. Capsule-equivalent to 50 mg doxycycline (No. 2 opaque white and light blue capsule) in: Bottles of 50 capsules NDC 53489-118-02 imprinted Mutual 100 Bottles of 500 capsules NDC 53489-118-05 imprinted Mutual 100 b.

Capsule-equivalent to 100 mg doxycycline (No. 0 opaque light blue capsule) in: Bottles of 50 capsules NDC 53489-119-02 imprinted Mutual 105 Bottles of 500 capsules NDC 53489-119-05 imprinted Mutual 105 c. Tablet-equivalent to 100 mg doxycycline (light orange film coated tablet) in: Bottles of 50 tablets NDC 53489-120-02 debossed MP 37 Bottles of 500 tablets NDC 53489-120-05 debossed MP 37 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Protect from Light.

📦 Storage and Handling 21 words ▾

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Protect from Light.

📋 Description 207 words ▾

DESCRIPTION Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding.

It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Doxycycline hyclate has the following structural formula: (C 22 H 24 N 2 O 8 •HCl) 2 •C 2 H 6 O•H 2 O M.W.

1025.89 (C 22 H 24 N 2 O 8 •HCl) 2 •C 2 H 6 O•H 2 O M.W. 1025.89 Each capsule for oral administration contains 50 mg or 100 mg doxycycline hyclate, equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, D&C Red #28, FD&C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide.

Each tablet for oral administration contains 100 mg doxycycline hyclate, equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide. Chemical Structure

💬 Information for Patients ~2 min read ▾

Information for Patients Patients taking doxycycline for malaria prophylaxis should be advised: — that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria. — to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact with mosquitoes, especially from dusk to dawn (e.g., staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent). — that doxycycline prophylaxis: — should begin 1–2 days before travel to the malarious area, — should be continued daily while in the malarious area and after leaving the malarious area, — should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area, — should not exceed 4 months.

All patients taking doxycycline should be advised: — to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (e.g., skin eruption, etc.) occurs. Sunscreen or sunblock should be considered. (See WARNINGS .) — to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration.

(See ADVERSE REACTIONS .) — that the absorption of tetracyclines is reduced when taken with foods, especially those which contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. (See DRUG INTERACTIONS .) — that the absorption of tetracyclines is reduced when taking bismuth subsalicylate.

(See DRUG INTERACTIONS .) — that the use of doxycycline might increase the incidence of vaginal candidiasis. Patients should be counseled that antibacterial drugs, including doxycycline hyclate should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When doxycycline hyclate is prescribed to treat a bacterial infection, patients should be told 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 doxycycline hyclate or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

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

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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Quality Care Products, LLC has reported a marketing end date of 2027-05-31, after which this package is expected to stop being marketed. 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 20 capsules (49999-0126-20), 30 capsules (49999-0126-30). 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?
Quality Care Products, LLC 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.
← 49999-0060-30 · Quality 49999-0265-14 · Quality →
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.