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Doxycycline Hyclate 100 mg Tablet, Film Coated, 400-count — NDC 24658-0310-08 package photo

Doxycycline Hyclate 100 mg Tablet, Film Coated, 400-count

by PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS · 400 TABLET, FILM COATED in 1 BOTTLE (24658-310-08)
NDC 24658-0310-08
🏷️ FDA NDC (as labeled) 24658-310-08 billing pads the product segment with a zero
This package
Contains400-count Cost per ea$0.1129 NADAC Per package$45.16 / 400 tablets Pack sizes9 compare ↓
Also priced by: Part D plans $0.2517/unit — full pricing hub ↓
Also comes in: 20 tablets 24658-0310-20 30 tablets 24658-0310-30 50 tablets 24658-0310-50 100 tablets 24658-0310-01 210 tablets 24658-0310-21 300 tablets 24658-0310-07 500 tablets 24658-0310-05 1000 tablets 24658-0310-10
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 →

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

FDA NDC (as labeled) 24658-310-08
Product NDC 24658-310
11-digit billing NDC 24658031008
NCPDP billing unit EA — each (per item)
RxCUI 1650143
UNII 19XTS3T51U
UPC 0324658310503, 0324658310213
Application # ANDA062269
SPL Set ID 65cac0b6-3550-48cf-bffa-cf42443c2731
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 2025-03-07
Route ORAL
Dosage form TABLET, FILM COATED
Substance DOXYCYCLINE HYCLATE
GPI-14 04000020100310
GCN Seq No 009223
GCN 40360
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 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 24658-310-08 — 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 → 24658-0310-08. 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

LabelerPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
Application holderEPIC PHARMA LLC
FDA applicationANDA062269 (ANDA)
Labeler code24658
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio36 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 100 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.

🧪 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.

💊 What it looks like

Color Brown
ShapeRound
Imprint312;E
Size9 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 L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 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.

💲 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 $0.113 $45.16 / 400 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 $0.2517 $100.68 / 400 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.124 $0.113
▼ Down 7% over the last 9 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 100 mg 00143-2112-05 Hikma 500 tablets $0.113 AB Availability likely —
Doxycycline Hyclate 100 mg 00591-5553-05 Actavis 500 tablets $0.113 — Availability likely —
Doxycycline Hyclate 100 mg 00904-0430-04 Major 1 tablet $0.113 AB Availability likely —
Doxycycline Hyclate 100 mgthis 24658-0310-08 PURACAP 400 tablets $0.113 AB Availability likely —
Doxycycline Hyclate 100 mg 27808-0234-01 Cranbury 50 tablets $0.113 AB Availability likely —
Doxycycline 100 mg 42192-0501-05 Acella 500 tablets $0.113 AB Availability likely —
Doxycycline Hyclate 100 mg 50268-0279-15 AvPAK 1 tablet $0.113 AB Availability likely —
Doxycycline Hyclate 100 mg 53489-0120-02 Sun 50 tablets $0.113 AB Availability likely —
Doxycycline Hyclate 100 mg 62135-0626-01 Chartwell 100 tablets $0.113 AB Availability likely —
Doxycycline Hyclate 100 mg 62584-0693-21 American 1 tablet $0.113 AB Availability likely —
Doxycycline Hyclate 100 mg 43386-0794-01 Lupin 100 tablets $0.141 AB FDA listed +25%
Doxycycline Hyclate 100 mg 00615-8529-14 NCS 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 33342-0392-05 Macleods 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 40032-0794-01 Novel 100 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 42708-0173-20 QPharma, 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 42806-0310-01 Epic 100 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 46708-0353-20 Alembic 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-4981-00 A-S 10 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-6133-00 A-S 10 tablets — AB Discontinued —
Doxycycline Hyclate 100 mg 50090-6134-06 A-S 2 tablets — AB Discontinued —
Doxycycline Hyclate 100 mg 50090-7546-00 A-S 10 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-7547-06 A-S 2 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-7580-00 A-S 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-7800-00 A-S 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 51407-0298-20 Golden 20 tablets — AB FDA listed —
Doxycycline 100 mg 55154-7128-00 Cardinal 1 tablet — AB FDA listed —
Doxycycline Hyclate 100 mg 55154-8079-00 Cardinal 1 tablet — AB FDA listed —
Doxycycline 100 mg 55289-0866-01 PD-Rx 100 tablets — AB FDA listed —
Doxycycline 100 mg 60429-0069-20 Golden 20 tablets — AB Discontinued —
Doxycycline Hyclate 100 mg 60760-0723-20 St. 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 62332-0353-20 Alembic 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 64380-0226-02 Strides 500 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-1431-01 RedPharm 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-1456-04 Redpharm 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-2075-02 Redpharm 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-2189-01 Redpharm 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-3466-07 NuCare 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-4836-07 NuCare 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-5265-02 NuCare 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68999-0626-02 Chartwell 20 tablets — AB FDA listed —
Doxycycline 100 mg 70518-3039-00 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-3213-01 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-3214-01 REMEDYREPACK 20 tablets — AB Discontinued —
Doxycycline 100 mg 70518-3363-00 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-3869-00 REMEDYREPACK 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-4510-00 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-4544-00 REMEDYREPACK 20 tablets — AB FDA listed —
Doxycycline hyclate 100 mg 70771-1104-00 Zydus 1000 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71205-0697-10 Proficient 10 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-1686-01 Bryant 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-2113-01 Bryant 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-2639-01 Bryant 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-9718-01 Bryant 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72162-2402-02 Bryant 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72189-0127-14 direct 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72189-0603-14 Direct_Rx 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72578-0001-01 Viona 100 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0276-14 PD-Rx 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0319-06 PD-Rx 6 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0419-14 PD-Rx 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 82804-0070-14 Proficient 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 82804-0173-14 Proficient 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 83112-0100-00 Health 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 51655-0998-20 Northwind 20 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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.
500 tablets24658-0310-05 88,902 Rx · $832,826
1000 tablets24658-0310-10 877 Rx · $131,625
100 tablets24658-0310-01 786 Rx · $21,586
300 tablets24658-0310-07 No Medicaid data
400 tablets this page24658-0310-08 No Medicaid data
20 tablets24658-0310-20 No Medicaid data
210 tablets24658-0310-21 No Medicaid data
30 tablets24658-0310-30 No Medicaid data
50 tablets24658-0310-50 No Medicaid data
Drug total (last 4 qtrs): 90,565 Rx · 1,995,244 units · $986,037 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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
24658-0310-01 100 TABLET, FILM COATED in 1 BOTTLE (24658-310-01) $0.1129 / ea $11.29 2025-03-07 Active
24658-0310-05 500 TABLET, FILM COATED in 1 BOTTLE (24658-310-05) $0.1129 / ea $56.46 2025-03-07 Active
24658-0310-07 300 TABLET, FILM COATED in 1 BOTTLE (24658-310-07) $0.1129 / ea $33.87 2025-04-14 Active
24658-0310-08 You're viewing this 400 TABLET, FILM COATED in 1 BOTTLE (24658-310-08) $0.1129 / ea $45.16 2025-04-14 Active
24658-0310-10 1000 TABLET, FILM COATED in 1 BOTTLE (24658-310-10) $0.1129 / ea $112.91 2025-03-07 Active
24658-0310-20 20 TABLET, FILM COATED in 1 BOTTLE (24658-310-20) $0.1129 / ea $2.26 2025-03-07 Active
24658-0310-21 210 TABLET, FILM COATED in 1 BOTTLE (24658-310-21) $0.1129 / ea $23.71 2025-04-14 Active
24658-0310-30 30 TABLET, FILM COATED in 1 BOTTLE (24658-310-30) $0.1129 / ea $3.39 2025-04-14 Active
24658-0310-50 50 TABLET, FILM COATED in 1 BOTTLE (24658-310-50) $0.1129 / ea $5.65 2025-03-07 Active

You're viewing one of 9 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 9 priced pack sizes ($0.1129 NADAC).

This pack shows little to no recent Medicaid volume — the 500 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 24658-0310-08?
NDC 24658-0310-08 is a 400-count package — 400 tablet, film coated in 1 bottle.
What is the difference between NDC 24658-0310-08 and NDC 24658-0310-20?
Both are Doxycycline Hyclate 100 mg Tablet, Film Coated — the drug itself is identical. NDC 24658-0310-08 is the 400-count package, while NDC 24658-0310-20 is the 20 tablets package.
What NDC number is used to bill for this package of Doxycycline Hyclate 100 mg Tablet, Film Coated?
Bill NDC 24658-0310-08 — the 11-digit billing format is 24658031008. 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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / 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 Chlamydophila 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. • Tularemia due to Francisella tularensis. • Cholera caused by Vibrio cholerae. • Campylobacter fetus infections caused by Campylobacter fetus. • Brucellosis due to Brucella species (in conjunction with streptomycin). • Bartonellosis due to Bartonella bacilliformis. • Granuloma inguinale caused by Klebsiella 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 bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: • Escherichia coli. • Enterobacter aerogenes. • Shigella species. • Acinetobacter 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. • 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 pallidum subspecies 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 section .)

⏱️ 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 hyclate tablets 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. Pediatric Patients: For all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage is 2.2 mg/kg of body weight administered every 12 hours. Children weighing 45 kg or more should receive the adult dose.

(See WARNINGS and PRECAUTIONS .) For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule is 4.4 mg/kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg/kg of body weight (given as a single daily dose or divided into twice daily doses). For pediatric patients weighing over 45 kg, 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 doxycycline 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 to 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 hyclate tablets, by mouth, twice a day for 60 days. CHILDREN: weighing less than 45 kg; 2.2 mg/kg of body weight by mouth, twice a day for 60 days. Children weighing 45 kg 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 ~3 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.

Use doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly when there are no alternative therapies. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline hyclate tablets, 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 the use of 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 may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving doxycycline. 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 .) If severe skin reactions occur, discontinue doxycycline hyclate tablets immediately and institute appropriate therapy.

Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline. 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 doxycycline should be avoided because isotretinoin 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.

0Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize. 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…

🤒 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, inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis. Hepatotoxicity has been reported rarely.

These reactions have been caused by both the oral and parenteral administration of tetracyclines. Superficial discoloration of the adult permanent dentition, reversible upon drug discontinuation and professional dental cleaning has been reported. Permanent tooth discoloration and enamel hypoplasia may occur with drugs of the tetracycline class when used during tooth development.

(See WARNINGS .) 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, fixed drug eruption, skin hyperpigmentation, 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 .) Immune: Hypersensitivity reactions including urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, and drug reaction with eosinophilia and systemic symptoms (DRESS), and Jarisch-Herxheimer reaction has been reported in the setting of spirochete infections treated with doxycycline. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported. Psychiatric: Depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination.

Other: Bulging fontanels in infants and intracranial hypertension in adults. (See WARNINGS. ) 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.

To report SUSPECTED ADVERSE REACTIONS, contact Blu Pharmaceuticals at 1-888-374-2791, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 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.

🧒 Pediatric Use 63 words ▾

Pediatric Use Because of the effects of drugs of the tetracycline-class on tooth development and growth, use doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly when there are no alternative therapies. (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 ~3 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 to 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 to 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.

Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 pediatric patients (2 to 18 years of age) showed that allometrically -scaled clearance (CL) of doxycycline in pediatric patients ≥2 to ≤8 years of age (median [range] 3.58 [2.27 to 10.82] L/h/70 kg, N =11) did not differ significantly from pediatric patients >8 to 18 years of age (3 .27 [1.11 to 8.12] L/h/70 kg, N=33). For pediatric patients weighing ≤45 kg, body weight normalized doxycycline CL in those ≥2 to ≤8 years of age (median [range] 0.071 [0 .041 to 0.202] L/kg/h, N=10) did not differ significantly from those >8 to 18 years of age (0.081 [0.035 to 0.126] L/kg/h, N=8).

In pediatric patients weighing >45 kg, no clinically significant differences in body weight normalized doxycycline CL were observed between those ≥2 to ≤8 years (0.050 L/kg/h, N=l) and those >8 to 18 years of age (0.044 [0.014 to 0.121] L/kg/h, N=25). No clinically significant difference in CL between oral and IV dosing was observed in the small cohort of pediatric patients who received the oral (N=19) or IV (N=21) formulation alone. Microbiology Mechanism of Action Doxycycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit.

Doxycycline has bacteriostatic activity against a broad range of Gram-positive and Gram-negative bacteria. Resistance Cross resistance with other tetracyclines is common. Antimicrobial Activity Doxycycline has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the package insert for doxycycline hyclate.

Gram-Negative Bacteria Acinetobacter species Bartonella bacilliformis Brucella species Klebsiella species Klebsiella granulomatis Campylobacter fetus Enterobacter aerogenes Escherichia coli Francisella tularensis Haemophilus ducreyi Haemophilus influenzae Neisseria gonorrhoeae Shigella species Vibrio cholerae Yersinia pestis Gram-Positive Bacteria Bacillus anthracis Listeria monocytogenes Streptococcus pneumoniae Anaerobic Bacteria Clostridium species Fusobacterium fusiforme Propionibacterium acnes Other Bacteria Nocardiae and other aerobic Actinomyces species Borrelia recurrentis Chlamydophila psittaci Chlamydia trachomatis Mycoplasma pneumoniae Rickettsiae Treponema pallidum Treponema pallidum subspecies pertenue Ureaplasma urealyticum Parasites Balantidium coli Entamoeba species 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 Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognize…

📦 How Supplied / Storage and Handling 154 words ▾

HOW SUPPLIED Doxycycline hyclate tablets, USP equivalent to 50 mg of doxycycline: Light beige, round convex beveled edge, film-coated tablets debossed “€” above “311” on one side and plain on the other. Bottles of 60 tablets NDC 24658-311-60 Doxycycline hyclate tablets, USP equivalent to 100 mg of doxycycline: Beige, round convex beveled edge, film-coated tablets debossed “€” above “312” on one side and plain on the other. Bottles of 20 tablets NDC 24658-310-20 Bottles of 30 tablets NDC 24658-310-30 Bottles of 50 tablets NDC 24658-310-50 Bottles of 100 tablets NDC 24658-310-01 Bottles of 210 tablets NDC 24658-310-21 Bottles of 300 tablets NDC 24658-310-07 Bottles of 400 tablets NDC 24658-310-08 Bottles of 500 tablets NDC 24658-310-05 Bottles of 1,000 tablets NDC 24658-310-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📋 Description 156 words ▾

DESCRIPTION Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets for oral administration. The chemical designation of doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula of doxycycline hyclate is: with a molecular formula of (C 22 H 24 N 2 O 8 •HCl) 2 •C 2 H 6 O•H 2 O and the molecular weight is 1025.89.

Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. 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. Active Ingredient: Doxycycline hyclate USP equivalent to 50 mg or 100 mg of doxycycline.

Inactive Ingredient: Microcrystalline cellulose and magnesium stearate. Tablet coating contains hypromellose, titanium dioxide, polyethylene glycol, FD&C yellow #6, polysorbate 80 and FD&C blue #2. Meet USP Dissolution Test 5. structural-formula

💬 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: o should begin 1to 2 days before travel to the malarious area, o should be continued daily while in the malarious area and after leaving the malarious area, o should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area, o 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 tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When doxycycline hyclate tablets are 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 ornot 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 tablets or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterials are discontinued. Sometimes after starting treatment with antibacterial drugs, 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 antibacterial drug. 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 ↗
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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.