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Oracea Doxycycline 40 mg Capsule, 192-count — NDC 00299-3822-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oracea Doxycycline 40 mg Capsule, 192-count — NDC 0299-3822-07 (Billing 00299-3822-07)

by Galderma Laboratories, L.P. · 24 TRAY in 1 BOX / 4 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK

This is a package of 192 capsules of Oracea Doxycycline 40 mg Capsule from Galderma Laboratories, L.P., no longer marketed (first marketed May 2010), no longer in the FDA NDC Directory.

NDC 00299-3822-07
🏷️ FDA NDC (as labeled) 0299-3822-07 billing pads the labeler segment with a zero
This package
Contains192-count Pack sizes6 compare ↓
Product page 00299-3822-30 Also comes in: 4 capsules 0299-3822-04 30 capsules 0299-3822-30 32 capsules 0299-3822-05 64 capsules 0299-3822-06 192 capsules 0299-3822-02
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

NDC database record

One package, one record: these facts belong to NDC 0299-3822-07 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0299 labeler · 3822 product · 07 package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0299382207 3
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0299-3822-07
Product NDC 0299-3822
11-digit billing NDC 00299382207
RxCUI 901399, 901401
UNII N12000U13O
Application # NDA050805
SPL Set ID aa15c93a-ff4c-447a-8a21-96da506d8997
Established class (EPC) Tetracycline-class Drug
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2010-05-14
Route ORAL
Dosage form CAPSULE
Substance DOXYCYCLINE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90060025006520
GPI class Oracea
Quick answers
  • GPI-14 (Medi-Span): 90060025006520
  • RxCUI (RxNorm): 901399
Why two NDCs? The FDA registers this code as 0299-3822-07 — a 4-4-2 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 labeler segment → 00299-3822-07. 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

📗 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 may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Doxycycline 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 4 capsules 30 capsules 32 capsules 64 capsules 192 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 Per unit Per pack Marketing startMarketing endStatus
00299-3822-02 0299-3822-02 12 TRAY in 1 BOX / 8 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK — — 2015-02-01 — Discontinued by firm
00299-3822-04 0299-3822-04 4 CAPSULE in 1 BLISTER PACK — — 2010-05-14 — Discontinued by firm
00299-3822-05 0299-3822-05 8 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK — — 2010-05-14 — Discontinued by firm
00299-3822-06 0299-3822-06 16 KIT in 1 BOX / 1 BLISTER PACK in 1 KIT / 4 CAPSULE in 1 BLISTER PACK — — 2010-05-14 — Discontinued by firm
00299-3822-07 You're viewing this 24 TRAY in 1 BOX / 4 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK — — 2015-02-01 — Discontinued by firm
00299-3822-30 0299-3822-30 Main listing 30 CAPSULE in 1 BOTTLE $29.08 / ea $872.28 2010-05-14 — Active

Pack size FAQ

What quantity is in this package?
This is a 192-count package — 24 tray in 1 box / 4 carton in 1 tray / 1 blister pack in 1 carton / 2 capsule in 1 blister pack.
How does this package differ from NDC 00299-3822-04?
Both are Oracea Doxycycline 40 mg Capsule — the drug itself is identical. This page's package is the 192-count one, while NDC 00299-3822-04 is the 4 capsules package.
What NDC number is used to bill for this package of Oracea Doxycycline 40 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.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxycycline 40 mg 11788-0134-30 AiPing 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 43547-0590-03 Solco 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 43598-0457-30 Dr.Reddys 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 60505-4775-03 Apotex 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 62332-0785-30 Alembic 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 68308-0668-30 Mayne 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 70748-0308-06 Lupin 30 capsules $4.671 AB Availability likely —
Oracea 40 mgthis 00299-3822-07 Galderma 192 capsules — AB Discontinued —
doxycycline 40 mg 33342-0346-07 Macleods 30 capsules — AB FDA listed —
Doxycycline 40 mg 46708-0785-30 Alembic 30 capsules — AB FDA listed —
Doxycycline 40 mg 73190-0040-30 AvKARE 30 capsules — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2006
First FDA approval
May 2006
📍
2026
Currently FDA-listed
20 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2027. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 26, 2006 AB TE-rated RLD RS ⏳ ~1.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 7749532 — method of use (U-1063)
2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026 2028
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 7749532 ↗ Method of use U-1063 Dec 19, 2027
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 brown
ShapeCapsule
ImprintGLD;40
Size18 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerGalderma Laboratories, L.P.
Application holderGALDERMA LABORATORIES LP
FDA applicationNDA050805 (NDA)
Labeler code00299
First marketedMay 2010
Product typeHuman Prescription Drug
Portfolio50 products on file

More NDCs from Galderma Laboratories, L.P. labeler code 00299

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 207 words ▾

1 INDICATIONS AND USAGE ORACEA is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ( 1. 1) Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections.

Do not use ORACEA for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. ( 1.2 ) ORACEA has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. ( 1.2 )

1.1Indication ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.

1.2Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use ORACEA for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated.

ORACEA has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.

⏱️ Dosage and Administration 159 words ▾

2 DOSAGE AND ADMINISTRATION Take one ORACEA capsule (40 mg) once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. ( 2.1 ) Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant microorganisms. ( 2.2 , 5.9 )

2.1General Dosing Information Take one ORACEA capsule (40 mg) once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration [ see Adverse Reactions (6) ].

2.2Important Considerations for Dosing Regimen The dosage of ORACEA differs from that of doxycycline used to treat infections. Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant organisms.

💊 Dosage Forms and Strengths 20 words ▾

3 DOSAGE FORMS AND STRENGTHS 40 mg beige opaque capsule imprinted with “GLD 40” 40 mg capsule. ( 3 )

⛔ Contraindications 37 words ▾

4 CONTRAINDICATIONS ​This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines. ORACEA is contraindicated in persons who have shown hypersensitivity to doxycycline or other tetracyclines. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS The use of ORACEA during tooth development (the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. ( 5.1 , 5.2 , 8.1 , 8.4 ) Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile . If C. difficile associated diarrhea occurs, discontinue ORACEA.

( 5.3 ) If renal impairment exists, ORACEA doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver injury. ( 5.4 ) Photosensitivity can occur with ORACEA; Patients should minimize or avoid exposure to natural or artificial sunlight. ( 5.5 ) Tetracyclines have been associated with the development of autoimmune syndromes; if symptoms develop, discontinue ORACEA immediately.

( 5.6 ) ORACEA may cause pseudotumor cerebri (benign intracranial hypertension). Discontinue ORACEA if symptoms occur. ( 5.8 ) Bacterial resistance to tetracyclines may develop in patients using ORACEA.

It should only be used as indicated. ( 5.9 )

5.1Inhibition of Bone Growth During Fetal and Pediatric Development Doxycycline, like other tetracycline-class drugs, may cause inhibition of bone growth when administered during the second and third trimesters of pregnancy, infancy, and childhood. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours.

This reaction was shown to be reversible when the drug was discontinued. If doxycycline is used during the second or third trimester of pregnancy, advise the patient of the potential risk to the fetus [ see Use in Specific Populations (8.1) ].

5.2Tooth Discoloration During Fetal and Pediatric Development The use of tetracycline class drugs orally during tooth development (last half of pregnancy, infancy, and childhood up 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 drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.

Use of tetracycline drugs is not recommended during tooth development [ see Use in Specific Populations (8.1) ].

5.3Clostridium difficile Associated Diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including doxycycline, 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 management should be instituted as clinically indicated.

5.4Metabolic Effects The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity.

Under such conditions, lower than usual total doses are indicated,… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Some of the most common adverse reactions (incidence >2% and more common than with placebo) are nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of ORACEA: In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received ORACEA or placebo over a 16-week period. The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of ≥1% for the active arm: Table 1.

Incidence (%) of Selected Adverse Reactions in Clinical Trials of ORACEA (n=269) v.s. Placebo (n=268) ORACEA Placebo Nasopharyngitis 13 (5) 9 (3) Pharyngolaryngeal Pain 3 (1) 2 (1) Sinusitis 7 (3) 2 (1) Nasal Congestion 4 (2) 2 (1) Fungal Infection 5 (2) 1 (0) Influenza 5 (2) 3 (1) Diarrhea 12 (5) 7 (3) Abdominal Pain Upper 5 (2) 1 (0) Abdominal Distention 3 (1) 1 (0) Abdominal Pain 3 (1) 1 (0) Stomach Discomfort 3 (1) 2 (1) Dry Mouth 3 (1) 0 (0) Hypertension 8 (3) 2 (1) Blood Pressure Increase 4 (2) 1 (0) Aspartate Aminotransferase Increase 6 (2) 2 (1) Blood Lactate Dehydrogenase Increase 4 (2) 1 (0) Blood Glucose Increase 3 (1) 0 (0) Anxiety 4 (2) 0 (0) Pain 4 (2) 1 (0) Back Pain 3 (1) 0 (0) Sinus Headache 3 (1) 0 (0) Note: Percentages based on total number of study participants in each treatment group.

Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity, Esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class. Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [ see Dosage and Administration (2) ].

Renal toxicity: Rise in BUN has been reported and is apparently dose-related [ see Warnings and Precautions (5.4) ]. Skin: maculopapular and erythematous rashes. Exfoliative dermatitis.

Photosensitivity is discussed above [ see Warnings and Precautions (5.5) ]. Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.

6.2Postmarketing Adverse Reactions Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of ORACEA. Nervous system : Pseudotumor cerebri (benign intracranial hypertension), headache.

Skin : fixed drug eruption Psychiatric : depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) Some bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. ( 7.2 ) The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. ( 7.3 )

7.1Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

7.2Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

7.3Methoxyflurane The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

7.4Antacids and Iron Preparations Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and iron-containing preparations.

7.5Oral Retinoids There have been reports of pseudotumor cerebri (benign intracranial hypertension) associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.

7.6Barbiturates and Anti-epileptics Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

7.7Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended ( 8.2 )

8.1Pregnancy Risk Summary Doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [ see Warnings and Precautions ( 5.1 and 5.2 ) ]. Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of ORECEA during the second and third trimester of pregnancy.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Data Human Data Published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. The use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short- term courses.

Animal Data Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.

8.2Lactation Risk Summary Based on available published data, doxycycline is likely to be present in human breast milk but the specific concentration in breastmilk is not clear. There is no information on the effects of doxycycline on the breastfed infant or the effects on milk production. Because there are other antibacterial drug options available to treat rosacea in lactating women and because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with ORACEA and for 5 days after the last dose.

8.4Pediatric Use ORACEA should not be used in infants and children less than 8 years of age [ see Warnings and Precautions (5.1) ]. ORACEA has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.

8.5Geriatric Use Clinical studies of ORACEA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [ see Warnings and Precautions ( 5.1 and 5.2 ) ]. Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of ORECEA during the second and third trimester of pregnancy.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Data Human Data Published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. The use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short- term courses.

Animal Data Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.

🧒 Pediatric Use 48 words ▾

8.4Pediatric Use ORACEA should not be used in infants and children less than 8 years of age [ see Warnings and Precautions (5.1) ]. ORACEA has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.

🧓 Geriatric Use 81 words ▾

8.5Geriatric Use Clinical studies of ORACEA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of ORACEA in the treatment of inflammatory lesions of rosacea is unknown.

12.3Pharmacokinetics ORACEA capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of ORACEA was investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic parameters for ORACEA following single oral doses and at steady-state in healthy subjects are presented in Table 2.

Table 2. Pharmcokinetic Parameters [Mean (± SD)] for ORACEA N C max Mean (ng/mL) T max Median (hr) AU 0-∞ (ng●hr/mL) t ½ (hr) Single Dose 40 mg capsules 30 510 ± 220.7 3.00 (1.0 - 4.1) 9227 ± 3212.8 21.2 ±

7.6Steady-State Day 7 40 mg capsules 31 600 ± 194.2 2.00 (1.0 - 4.0) 7543 ± 2443.9 23.2 ±

6.2Absorption: In a single-dose food-effect study involving administration of ORACEA to healthy volunteers, concomitant administration with a 1000 calorie, high-fat, high-protein meal that included dairy products, resulted in a decrease in the rate and extent of absorption (C max and AUC) by about 45% and 22%, respectively, compared to dosing under fasted conditions. This decrease in systemic exposure can be clinically significant, and therefore if ORACEA is taken close to meal times, it is recommended that it be taken at least one hour prior to or two hours after meals.

Distribution: Doxycycline is greater than 90% bound to plasma proteins. Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. Terminal half-life averaged 21.2 hours in subjects receiving a single dose of ORACEA.

Special Populations Geriatric: Doxycycline pharmacokinetics have not been evaluated in geriatric patients. Pediatric: Doxycycline pharmacokinetics have not been evaluated in pediatric patients [ see Warnings and Precautions (5.1) ] Gender: The pharmacokinetics of ORACEA were compared in 16 male and 14 female subjects under fed and fasted conditions. While female subjects had a higher C max and AUC than male subjects, these differences were thought to be due to differences in body weight/lean body mass.

Race: Differences in doxycycline pharmacokinetics among racial groups have not been evaluated. Renal Insufficiency: Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function. Hemodialysis does not alter the serum half-life of doxycycline.

Hepatic Insufficiency: Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency. Gastric Insufficiency: In a study in healthy volunteers (N=24) the bioavailability of doxycycline is reported to be reduced at high pH. This reduced bioavailability may be clinically significant in patients with gastrectomy, gastric bypass surgery or who are otherwise deemed achlorhydric.

Drug Interactions: [ see Drug Interactions (7) ].

12.4Microbiology Doxycycline is a member of the tetracycline-class of drugs. The plasma concentrations of doxycycline achieved with ORACEA during administration [ see Clinical Pharmacology (12.3) and Dosage and Administration (2.2) ] are less than the concentration required to treat bacterial diseases. ORACEA should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease [ see Indications and Usage (1.2) ].

In vivo microbiological studies utilizing a similar drug exposure for up to 18 months demonstrated no detectable long term effects on bacterial flora of the oral cavity, skin, intestinal tract and vagina.

🧬 Mechanism of Action 20 words ▾

12.1Mechanism of Action The mechanism of action of ORACEA in the treatment of inflammatory lesions of rosacea is unknown.

📦 How Supplied / Storage and Handling 62 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ORACEA (beige opaque capsule imprinted with “GLD 40”) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 (NDC 0299-3822-30). Storage: All products are to be stored at controlled room temperatures of 59°F - 86°F (15°C - 30°C) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.

📋 Description 127 words ▾

11 DESCRIPTION ORACEA (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22 H 24 N 2 O 8 ). The structural formula of doxycycline, USP is: with an empirical formula of C 22 H 24 N 2 O 8 •H 2 O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate.

It is very slightly soluble in water. Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate. oracea-chem-struct

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Patients taking ORACEA Capsules 40 mg should receive the following information and instructions: Advise pregnant women that doxycycline, like other tetracycline-class drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [ see Warnings and Precautions ( 5.1 and 5.2 ) and Use in Specific Populations ( 8.1 ) ]. Advise women not to breastfeed during treatment with ORACEA and for 5 days after the last dose [ see Use in Specific Populations ( 8.2 ) ].

Advise patients that use of tetracycline class drugs orally during tooth development (infancy and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Advise patients that use of doxycycline, like other tetracycline-class drugs, may cause inhibition of bone growth when administered during infancy and childhood. Advise patients that pseudomembranous colitis can occur with doxycycline therapy.

If patients develop watery or bloody stools, they should seek medical attention. Advise patients that pseudotumor cerebri can occur with doxycycline therapy. If patients experience headache or blurred vision they should seek medical attention.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including doxycycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using doxycycline. If patients need to be outdoors while using doxycycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.

Treatment should be discontinued at the first evidence of sunburn. Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including doxycycline. Symptoms may be manifested by arthralgia, fever, rash and malaise.

Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help. Counsel patients about discoloration of skin, scars, teeth or gums that can arise from doxycycline therapy. Advise patients to take ORACEA exactly as directed.

Increasing doses beyond 40 mg every morning may increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics ORACEA capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of ORACEA was investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic parameters for ORACEA following single oral doses and at steady-state in healthy subjects are presented in Table 2.

Table 2. Pharmcokinetic Parameters [Mean (± SD)] for ORACEA N C max Mean (ng/mL) T max Median (hr) AU 0-∞ (ng●hr/mL) t ½ (hr) Single Dose 40 mg capsules 30 510 ± 220.7 3.00 (1.0 - 4.1) 9227 ± 3212.8 21.2 ±

7.6Steady-State Day 7 40 mg capsules 31 600 ± 194.2 2.00 (1.0 - 4.0) 7543 ± 2443.9 23.2 ±

6.2Absorption: In a single-dose food-effect study involving administration of ORACEA to healthy volunteers, concomitant administration with a 1000 calorie, high-fat, high-protein meal that included dairy products, resulted in a decrease in the rate and extent of absorption (C max and AUC) by about 45% and 22%, respectively, compared to dosing under fasted conditions. This decrease in systemic exposure can be clinically significant, and therefore if ORACEA is taken close to meal times, it is recommended that it be taken at least one hour prior to or two hours after meals.

Distribution: Doxycycline is greater than 90% bound to plasma proteins. Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. Terminal half-life averaged 21.2 hours in subjects receiving a single dose of ORACEA.

Special Populations Geriatric: Doxycycline pharmacokinetics have not been evaluated in geriatric patients. Pediatric: Doxycycline pharmacokinetics have not been evaluated in pediatric patients [ see Warnings and Precautions (5.1) ] Gender: The pharmacokinetics of ORACEA were compared in 16 male and 14 female subjects under fed and fasted conditions. While female subjects had a higher C max and AUC than male subjects, these differences were thought to be due to differences in body weight/lean body mass.

Race: Differences in doxycycline pharmacokinetics among racial groups have not been evaluated. Renal Insufficiency: Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function. Hemodialysis does not alter the serum half-life of doxycycline.

Hepatic Insufficiency: Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency. Gastric Insufficiency: In a study in healthy volunteers (N=24) the bioavailability of doxycycline is reported to be reduced at high pH. This reduced bioavailability may be clinically significant in patients with gastrectomy, gastric bypass surgery or who are otherwise deemed achlorhydric.

Drug Interactions: [ see Drug Interactions (7) ].

🔬 Clinical Studies ~3 min read ▾

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of ORACEA: In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received ORACEA or placebo over a 16-week period. The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of ≥1% for the active arm: Table 1.

Incidence (%) of Selected Adverse Reactions in Clinical Trials of ORACEA (n=269) v.s. Placebo (n=268) ORACEA Placebo Nasopharyngitis 13 (5) 9 (3) Pharyngolaryngeal Pain 3 (1) 2 (1) Sinusitis 7 (3) 2 (1) Nasal Congestion 4 (2) 2 (1) Fungal Infection 5 (2) 1 (0) Influenza 5 (2) 3 (1) Diarrhea 12 (5) 7 (3) Abdominal Pain Upper 5 (2) 1 (0) Abdominal Distention 3 (1) 1 (0) Abdominal Pain 3 (1) 1 (0) Stomach Discomfort 3 (1) 2 (1) Dry Mouth 3 (1) 0 (0) Hypertension 8 (3) 2 (1) Blood Pressure Increase 4 (2) 1 (0) Aspartate Aminotransferase Increase 6 (2) 2 (1) Blood Lactate Dehydrogenase Increase 4 (2) 1 (0) Blood Glucose Increase 3 (1) 0 (0) Anxiety 4 (2) 0 (0) Pain 4 (2) 1 (0) Back Pain 3 (1) 0 (0) Sinus Headache 3 (1) 0 (0) Note: Percentages based on total number of study participants in each treatment group.

Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity, Esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class. Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [ see Dosage and Administration (2) ].

Renal toxicity: Rise in BUN has been reported and is apparently dose-related [ see Warnings and Precautions (5.4) ]. Skin: maculopapular and erythematous rashes. Exfoliative dermatitis.

Photosensitivity is discussed above [ see Warnings and Precautions (5.5) ]. Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.

14 CLINICAL STUDIES The safety and efficacy of ORACEA in the treatment of only inflammatory lesions (papules and pustules) of rosacea was evaluated in two randomized, placebo-controlled, multi-centered, double-blind, 16-week Phase 3 trials involving 537 subjects (total of 269 subjects on ORACEA from the two trials) with rosacea (10 to 40 papules and pustules and two or fewer nodules). Mean baseline lesion counts were 20 and 21 for ORACEA and placebo subject groups respectively. Pregnant and nursing women, subjects <18 years of age, and subjects with ocular rosacea and/or blepharitis/meibomianitis who require ophthalmologic treatment were excluded from trials.

At Week 16, subjects in the ORACEA group were evaluated using co-primary endpoints of mean reduction in lesion counts and a dichotomized static Investigator’s Global Assessment of Clear or Almost Clear (defined as 1 to 2 small papules or pustules) when compared to the placebo group in both Phase 3 trials. Table 3: Clinical Results of ORACEA versus Placebo Study 1 Study 2 ORACEA Placebo ORACEA Placebo 40 mg N=127 N=124 40 mg N=142 N=144 Mean Change in Lesion Count from Baseline - 11.8 - 5.9 - 9.5 -

4.3No. (%) of Subjects Clear or Almost Clear in the IGA Investigator's Global Assessment 39 (30.7%) 24 (19.4%) 21 (14.8%) 9 (6.3%) Subjects treated with ORACEA did not demonstrate significant improvement in erythema when comp… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use ORACEA [exposure comparison based upon area under the curve (AUC) values].

No impact upon tumor incidence was observed in male rats up to at 200 mg/kg/day, or in females at the lower dosages studied. Doxycyline was assessed for potential to induce carcinogenesis in CD-1 mice by gavage at dosages 20, 75, and 150 mg/kg/day in males and at dosages of 20, 100, and 300 mg/kg/day in females. No impact upon tumor incidence was observed in male and female mice at systemic exposures approximately 4.2 and 8.3 times that observed in humans, respectively.

Doxycycline demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro mammalian chromosomal aberration assay conducted with CHO cells suggest that doxycycline is a weak clastogen. Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses.

Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of ORACEA when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of ORACEA on human fertility is unknown.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use ORACEA [exposure comparison based upon area under the curve (AUC) values].

No impact upon tumor incidence was observed in male rats up to at 200 mg/kg/day, or in females at the lower dosages studied. Doxycyline was assessed for potential to induce carcinogenesis in CD-1 mice by gavage at dosages 20, 75, and 150 mg/kg/day in males and at dosages of 20, 100, and 300 mg/kg/day in females. No impact upon tumor incidence was observed in male and female mice at systemic exposures approximately 4.2 and 8.3 times that observed in humans, respectively.

Doxycycline demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro mammalian chromosomal aberration assay conducted with CHO cells suggest that doxycycline is a weak clastogen. Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses.

Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of ORACEA when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of ORACEA on human fertility is unknown.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION ORACEA (Or-RAY-sha) (doxycycline) capsules Read this Patient Information before you start taking ORACEA and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is ORACEA? ORACEA is a tetracycline-class medicine. ORACEA is a prescription medicine used in adults to treat only pimples or bumps (papules and pustules) caused by a condition called rosacea.

ORACEA does not lessen redness caused by rosacea. ORACEA should not be used for the treatment or prevention of infections. It is not known if ORACEA is: effective for use for longer than 16 weeks. safe for use longer than 9 months. safe and effective in children.

ORACEA should not be used in infants and children less than 8 years of age because it may cause stained teeth in infants and children. Who should not take ORACEA? Do not take ORACEA if you are allergic to doxycycline or other medicines in the tetracycline-class.

Ask your doctor or pharmacist for a list of these medicines if you are not sure. What should I tell my doctor before taking ORACEA? Before you take ORACEA tell your doctor if you: have kidney problems. have liver problems. have diarrhea or watery stools. have vision problems. have had surgery on your stomach (gastric surgery). have or had a yeast or fungal infection in your mouth or vagina. have any other medical condition. • are pregnant or plan to become pregnant.

ORACEA may harm your unborn baby. Taking ORACEA while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking ORACEA and call your doctor right away if you become pregnant while taking ORACEA. are breastfeeding or plan to breastfeed.

ORACEA can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take ORACEA. You and your doctor should decide if you will take ORACEA or breastfeed.

You should not do both. Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ORACEA and other medicines can affect each other causing serious side effects.

Especially tell your doctor if you take: a blood thinner medicine. a penicillin (antibacterial medicine). proton pump inhibitors or antacids that contain aluminum, calcium, or magnesium. products containing iron or bismuth subsalicylate. a medicine taken by mouth that contains isotretinoin or acitretin. a medicine to treat seizures, such as carbamazepineor or phenytoin. Ask your doctor or pharmacist for a full list of these medicines, if you are not sure. Know the medicines you take.

Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. How should I take ORACEA? Take ORACEA exactly as prescribed by your doctor.

Taking more than your prescribed dose may increase your chance of side effects, including the chance that bacteria will become resistant to ORACEA. Take ORACEA 1 time a day in the morning on an empty stomach. You should take ORACEA at least one hour before or two hours after a meal.

Take ORACEA with enough fluid to completely swallow the capsule and to lower your risk of getting irritation or ulcer in your esophagus. Your esophagus is the tube that connects your mouth to your stomach. If you took too much ORACEA call your doctor right away.

Your doctor may do blood tests during treatment with ORACEA to check for side effects. What should I avoid while taking ORACEA? Avoid sunlight or artificial sunlight, such as a tanning booth or sunlamp.

You could get severe sunburn. Use sunscreen and wear clothes that cover your skin while out in sunlight. What are the possible side effects of ORACEA?

ORACEA may cause serious side effects, including: Harm to an unborn baby. See “ What should I tell my doctor before taking ORACEA? ” P ermanent teeth discoloration . ORACEA may permanently turn a bab… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 48 words ▾

PACKAGE LABEL NDC 0299-3822-30 ORACEA ® (doxycycine, USP) capsules 40 mg * * 30 mg IMMEDIATE RELEASE & 10 mg DELAYED RELEASE BEADS 30 CAPSULES RX ONLY GALDERMA Marketed by: Galderma Laboratories, L.P. Dallas, TX 75201 USA All trademarks are the property of their respective owners. oracea.com P55303-1

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

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.
30 capsules00299-3822-30 65 Rx · $57,436
192 capsules00299-3822-02 No Medicaid data
4 capsules00299-3822-04 No Medicaid data
32 capsules00299-3822-05 No Medicaid data
64 capsules00299-3822-06 No Medicaid data
192 capsules this page00299-3822-07 No Medicaid data
Drug total (last 4 qtrs): 65 Rx · 1,950 units · $57,436 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 Oracea — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Oracea. 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
$432.8K
Claims incl. refills
336
Beneficiaries
205
Spend / beneficiary
$2,111.37
Spend / claim
$1,288.18
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 No longer marketed (per FDA listing data)
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 4 capsules (00299-3822-04), 30 capsules (00299-3822-30), 32 capsules (00299-3822-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Galderma Laboratories, L.P. 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.
← 00299-2012-05 · Galderma 00299-3823-00 · Galderma →
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.