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Standardized Mite Dermatophagoides farinae 10000 [AU]/mL Concentrate, 5 mL — NDC 22840-0034-03 package photo
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Standardized Mite Dermatophagoides farinae 10000 [AU]/mL Concentrate, 5 mL — NDC 22840-0034-3 (Billing 22840-0034-03)

by Greer Laboratories, Inc. · 5 mL in 1 BOTTLE, DROPPER

This is a package of 5 mL of Standardized Mite Dermatophagoides farinae 10000 [AU]/mL Concentrate from Greer Laboratories, Inc., marketed since Feb 1987 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 22840-0034-03
🏷️ FDA NDC (as labeled) 22840-0034-3 billing pads the package segment with a zero
This package
Contains5 mL Pack sizes4 compare ↓
Main listing for product 22840-0034 · Also comes in: 10 ml 22840-0034-6 30 ml 22840-0034-8 50 ml 22840-0034-9
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 22840-0034-3 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
22840 labeler · 0034 product · 3 package
Package marketed since
Feb 2, 1987
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 2284000343 1
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 22840-0034-3
Product NDC 22840-0034
11-digit billing NDC 22840003403
RxCUI 852813, 852825, 852829, 854052, 854068, 1014384, 1192787
UNII 57L1Z5378K, PR9U2YPF3Q
Application # BLA101834
SPL Set ID 9b7f878e-613f-4831-9223-a6a07fb09f1b
Established class (EPC) Standardized Insect Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Antigens, Dermatophagoides; Insect Proteins; Allergens
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1987-02-02
Route INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Dosage form CONCENTRATE
Substance DERMATOPHAGOIDES FARINAE
Biologic (Purple Book) 351(a)

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

GPI-14 20100002102020
GPI class Mite (D. farinae)
Quick answers
  • GPI-14 (Medi-Span): 20100002102020
  • RxCUI (RxNorm): 852813
Why two NDCs? The FDA registers this code as 22840-0034-3 — a 5-4-1 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 package segment → 22840-0034-03. 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 Standardized Insect Allergenic Extract class.

Pharmacologic class Standardized Insect Allergenic Extract
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

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 mLPer 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: 10 ml 30 ml 50 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
22840-0034-03 You're viewing this Main listing 5 mL in 1 BOTTLE, DROPPER 1987-02-02 — Active
22840-0034-06 22840-0034-6 10 mL in 1 VIAL, MULTI-DOSE 1987-02-02 — Active
22840-0034-08 22840-0034-8 30 mL in 1 VIAL, MULTI-DOSE 1987-02-02 — Active
22840-0034-09 22840-0034-9 50 mL in 1 VIAL, MULTI-DOSE 1987-02-02 — Active

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 5 mL — 5 ml in 1 bottle, dropper.
How does this package differ from NDC 22840-0034-06?
Both are Standardized Mite Dermatophagoides farinae 10000 [AU]/mL Concentrate — the drug itself is identical. This page's package is the 5 mL one, while NDC 22840-0034-06 is the 10 ml package.
What NDC number is used to bill for this package of Standardized Mite Dermatophagoides farinae 10000 [AU]/mL Concentrate?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Standardized Mite D. farinae 10000 [AU]/mL 00268-0275-10 ALK-Abello, 10 ml — — FDA listed —
Standardized Mite D. farinae 10000 [AU]/mL 00268-7000-06 ALK-Abello, 5 ml — — FDA listed —
Standardized Mite Dermatophagoides farinae 10000 [AU]/mLthis 22840-0034-03 Greer 5 ml — — FDA listed —
House Dust Mite, Dermatophagoides farinae 10000 [AU]/mL 49643-0702-05 Allermed 5 ml — — FDA listed —
Standardized Mite, Dermatophagoides farinae, Bulk, 10000 AU per mL 10000 [AU]/mL 65044-6723-02 Jubilant 10 ml — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
1958
First FDA approval
Sep 1958
📍
2026
Currently FDA-listed
68 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGreer Laboratories, Inc.
FDA applicationBLA101834 (BLA)
Labeler code22840
First marketedFeb 1987
Product typeHuman Prescription Drug
Portfolio1,328 products on file

More NDCs from Greer Laboratories, Inc. labeler code 22840

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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: ANAPHYLAXIS Do not inject intravenously. (2.2) Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death. (5.1) This allergenic product is intended for use only by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist.

(5.1) The initial dose must be based on skin test. (2.1) Observe patients in the office for at least 30 minutes following treatment. Emergency measures and personnel trained in their use must be available immediately in the event of life threatening reaction.

(5.1) Immunotherapy may not be suitable for patients with medical conditions that reduce their ability to survive a systemic reaction, including significant cardiovascular and/or pulmonary diseases. Patients who are receiving beta blockers may be unresponsive to the usual doses of epinephrine used to treat systemic reactions, including anaphylaxis. (5.2) WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning.

Do not inject intravenously (2.2) Allergenic extracts may cause severe life-threatening systemic reactions, including the rare occurrence of anaphylaxis or death (5.1) Intended for use only by experts experienced in administering allergic extracts and trained to provide emergency treatment (5.1) Initial dose must be based on skin test (2.1) Observe patients in the office for at least 30 minutes following treatment. Emergency measures and personnel trained in their use must be available immediately in the event of life threatening reaction (5.1) Immunotherapy may not be suitable for patients with medical conditions that reduce their ability to survive a systemic reaction (5)

🎯 Indications and Usage 115 words ▾

1 INDICATIONS AND USAGE Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) Extracts are allergenic extracts indicated for: skin test diagnosis of mite allergy treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis. For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae ( D. farinae ) or Dermatophagoides pteronyssinus ( D. pteronyssinus ) based on their clinical history, allergen exposure history, and skin test reactivity.

Greer Standardized Mite Extracts are allergenic extracts indicated for: Diagnosis of skin test reactivity to dust mite allergen (1) Treatment of mite-induced allergic asthma, rhinitis and conjunctivitis in patients that show hypersensitivity to dust mites based on clinical history, allergen exposure history, and skin test reactivity (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Do not inject intravenously. Greer Standardized Mite extracts are diluted with sterile diluent for allergenic extracts when used for intradermal testing or subcutaneous immunotherapy. Dosages vary by mode of administration, and by individual response and tolerance.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Greer Standardized Mite Extracts should be a light brown solution that is free of particulate matter. If particulate matter is observed then the solution should be discarded.

2.1Diagnostic Testing For diagnosis of a patient with a suspected allergy to either species of dust mite ( D. farinae or D. pteronyssinus ), diagnostic skin testing should include the standardized mite mixture or the single-species mite extracts. If a skin test with the standardized mite mixture elicits a positive reaction, then the single-species mite extracts can be used to determine the degree of sensitivity to each, and to guide in the selection of extracts and their concentration for immunotherapy, if indicated.

A positive skin test reaction to any allergen must be interpreted in light of the patient's history of symptoms, the time of year, and known exposure to environmental allergens. 2.1.1 Percutaneous Skin Testing For percutaneous (scratch, prick, or puncture) testing, use 10,000 Allergy Units/mL Greer Standardized Mite Extract stock concentrate in dropper vials. If patient is suspected of having exquisite sensitivity, such as anaphylaxis, to certain foods and drugs, initiate percutaneous testing with several serial 10-fold dilutions of the usual test concentration.

For scratch tests, scarify the skin, and then apply one drop of the extract to the scratch. For prick tests, place one drop of extract on the skin and pierce through the drop into the skin with a slight lifting motion. For puncture tests, place one drop of extract on the skin and pierce through the drop perpendicular to the skin.

When using percutaneous test devices, follow the directions provided with the test devices. Include a positive control to detect false negative responses to skin testing, which may occur if serum levels of antihistamines remain from prior medication administration [see Drug Interactions (7.2)]. A glycerinated histamine phosphate diluted to 10 mg/mL (6 mg/mL histamine base) may be used as the positive control.

Include a negative control to detect false positive responses, which can occur when the patient has a non-specific reaction to the diluent. A 50% glycerosaline solution may be used as the negative control. Read skin tests 15-20 minutes after exposure.

Record the induration (wheal) and erythema (flare) response by noting the longest diameter of each, or by the sum of the longest erythema diameter and the mid-point orthogonal diameters of erythema (ΣE). Percutaneous testing devices often have their own grading systems, as these devices may cause different degrees of trauma to the skin and deliver different volumes of allergenic extract. Follow grading instructions for the device used.

2.1.2Intradermal Skin Testing Intradermal tests are commonly used when the reaction to percutaneous testing is negative or equivocal but the patient has a strong clinical history of symptoms triggered by exposure to a specific allergen. Because immediate systemic reactions are more common with intradermal testing, prescreening with percutaneous testing is a practical safety measure. 1 Dilute the stock concentrate with sterile diluent.

Use saline with human serum albumin (HSA), buffered saline, or saline. If prescreening is not done, or if patients are expected to be high risk, precautions should be observed since some patients have experienced anaphylaxis and death. Patients who do not react to percutaneous skin testing should be tested intradermally at a starting dose of 0.02 to 0.05 mL of a 50 Allergy Units/mL extract dilution… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline. For intradermal testing extracts may be diluted in normal saline, buffered saline, or albumin saline. Greer Standardized Mite Extract D. farinae and Greer Standardized Mite Extract D. pteronyssinus are supplied as stock concentrates containing 10,000 Allergy Units/mL and Greer Standardized Mite Extract mixture ( D. farinae and D. pteronyssinus ) is supplied as a stock mixture concentrate containing 5,000 Allergy Units/mL of each species for use in percutaneous skin testing.

Greer Standardized Mite Extract D. farinae and Greer Standardized Mite Extract D. pteronyssinus are supplied as stock concentrates containing 5,000, 10,000, or 30,000 Allergy Units/mL. Greer Standardized Mite Extract mixture ( D. farinae and D. pteronyssinus ) is supplied as a stock mixture concentrate containing 5,000 and 15,000 Allergy Units/mL of each species for use in intradermal testing and immunotherapy. For percutaneous testing, Greer Standardized Mite Extract stock concentrates containing 10,000 Allergy Units/mL of Dermatophagoides farinae ( D. farinae ), Dermatophagoides pteronyssinus ( D. pteronyssinus ), or both D. farinae and D. pteronyssinus are supplied in 5 mL dropper vials (3) For intradermal testing or immunotherapy, Greer Standardized Mite Extracts stock concentrates containing a total of 5,000, 10,000 or 30,000 Allergy Units/mL of D. farinae , D. pteronyssinus , or a mixture of D. farinae and D. pteronyssinus are supplied in 10, 30 and 50 mL multiple-dose vials (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None. None (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS

5.1Serious Systemic Reactions All concentrates of Greer Standardized Mite Extracts have the ability during skin testing and immunotherapy to elicit serious systemic reactions including anaphylactic shock and death [see Adverse Reactions (6)]. A review of the literature indicates that the incidence of near-fatal reactions to immunotherapy, defined as severe respiratory compromise, hypotension, or both, and requiring emergency treatment with epinephrine, has been estimated as 5.4 events per million injections in a 10-year retrospective survey of allergists.

3 Fatalities from immunotherapy injections have been estimated to occur at a rate of approximately one death per 2.0 to 2.8 million injections in 4-, 10- and 12-year retrospective surveys of allergists. 4-6 Because of the danger of serious reactions, caution is required in testing and treating high risk patients and those with medical conditions that reduce their ability to survive a serious systemic adverse event. High-risk patients are defined as those patients: with labile or steroid-dependent asthma, particularly in those suffering an exacerbation of their symptoms at the time of extract administration; with extreme sensitivity to a particular allergen(s); who are currently using beta blockers; who are receiving an accelerated immunotherapy build-up schedule (e.g., rush immunotherapy); who are being changed from one allergenic extract to another; who are receiving high doses of allergenic extracts.

High risk patients have had fatal reactions. In addition, patients not high-risk but on beta blockers have had fatal reactions because beta blockers interfere with beta adrenergics such as epinephrine used in treatment or anaphylaxis. Patients should be kept under observation for a minimum of 30 minutes after receiving allergenic extracts so that any adverse reaction can be observed and properly handled.

2 Medications to treat systemic reactions, as well as emergency equipment should be available for immediate use. Extracts must only be administered by persons who are aware of the risk of systemic reactions, including anaphylaxis; are capable of handling such reactions; and have the necessary drugs and equipment on hand to do so.

5.2Patients on Beta Blockers Patients receiving beta blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Inhalant allergy immunotherapy should be approached with caution in patients taking beta blockers. The risks of anaphylaxis in these patients should be carefully weighed against the benefits of immunotherapy [see Drug Interactions (7.1)].

5.3Autoimmune Disease Immunotherapy should be given cautiously to patients with other immunologic diseases and only if the risk from exposure to the allergen is greater than the risk of exacerbating the underlying disorder. 2 All concentrates of Greer Standardized Mite Extracts can cause serious systemic reactions of varying degrees of severity, including anaphylactic shock and death, particularly in patients: With labile or steroid-dependent asthma (5.1) With extreme sensitivity to allergen(s) (5.1) Who are currently using beta blockers (5.2) Who are on an accelerated immunotherapy build-up schedule (5.1) Who are being changed from one allergenic extract to another (5.1) Who are receiving high doses of allergen extracts (5.1)

🤒 Adverse Reactions 211 words ▾

6 ADVERSE REACTIONS Systemic reactions consist primarily of allergic symptoms, such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. Additional symptoms that are not usually associated with allergy also may occur, such as nausea, emesis, abdominal cramps, and diarrhea. Serious reactions may cause shock, loss of consciousness, and even death.

Based on published studies, 7,8 systemic reactions occur in less than 1% of patients receiving conventional immunotherapy to greater than 36% in some studies of patients receiving rush immunotherapy. Local reactions at the injections site are the most commonly occurring reactions (e.g., erythema, itching, swelling, tenderness, pain). Although most adverse systemic reactions occur within 30 minutes of injection (some within minutes of extract exposure), such reactions also can occur up to six hours after skin tests or immunotherapy [see Dosage and Administration (2.2)].

9 Systemic reactions may be fatal or near fatal (6) Systemic reactions (e.g. generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension) occur in 4-7% of patients The most common reactions are local reactions at the injection site (e.g., erythema, itching, swelling, tenderness, pain), occuring in 26% to 82% of patients (6) To report SUSPECTED ADVERSE REACTIONS, contact Greer Laboratories, Inc., at 1-855-274-1322 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1Beta Adrenergic Drugs Patients receiving beta blocker drugs may not be responsive to beta adrenergic drugs used to treat anaphylaxis 10 , and may wish to temporarily postpone treatment day of skin testing. All such decisions should be made in consultation with the physician [see Warnings and Precautions (5.2)].

7.2Antihistamines 1 Skin testing with allergenic extracts should not be performed within 2-3 days of first-generation H 1 -histamine receptor blockers (e.g., clemastine, diphenhydramine) and within 3 to 10 days of second-generation antihistamines (e.g., loratadine, terfenadine), except for astemizole, which requires an interval of 30-60 days between allergenic extract exposure and use. These products suppress histamine skin test reactions and could mask a positive response.

7.3Topical Corticosteroids and Topical Anesthetics 1 Topical corticosteroids may suppress skin reactivity and should be discontinued at the skin test site for at least 2-3 weeks before skin testing. Topical local anesthetics may suppress flare responses and should be avoided at skin test sites.

7.4Tricyclic Antidepressants 1 Tricyclic antidepressants can have potent antihistamine effects and will affect skin testing. Since use of tricyclics may alter skin test results, dosing for both skin testing and immunotherapy should be done with caution. If tricyclic medication has been recently discontinued, allow 7-14 days prior to skin testing to obviate the antihistamine effect.

The risk of anaphylaxis in these patients should be carefully weighed against the risks and benefits of stopping tricyclics.

7.5Other Drugs The suppressive action of other drugs should be considered and emphasizes the need for a histamine positive-control test. Patients who are receiving beta agonists may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis (7.1) Patients should discontinue medications known to suppress the histamine response prior to skin testing including: antihistamines (7.2), tricyclics (7.4), and topical corticosteroids and topical anesthetics (7.3)

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with Greer Standardized Mite Extracts. It is also not known whether Greer Standardized Mite Extracts can cause fetal harm when administered to a pregnant woman or whether they can affect reproduction capacity. Standardized Mite Extracts should be given to a pregnant woman only if clearly needed.

Studies have not been performed in animals to determine whether extracts affect fertility in males or females, have teratogenic potential, or have other adverse affects on the fetus. Exercise caution in testing or treating pregnant females because a systemic reaction may cause maternal cardiovascular compromise leading to fetal distress with sequelae.

8.3Nursing Mothers It is not known whether allergenic extracts or their antigens are excreted in human milk. Because many drugs are excreted in human milk, exercise caution when extracts are administered to a nursing woman.

8.4Pediatric Use No studies have systematically examined differences in response to immunotherapy among child and adult patients. Children appear to tolerate injections of allergenic extracts very well. 2 Very young children (under age 5) can have difficulty cooperating with an immunotherapy program and for this reason, the physician should consider the benefits and risks of immunotherapy and indiviualize treatment in patients under the age of 5 years [see Warnings and Precautions (5)].

8.5Geriatric Use Clinical studies of Greer Standardized Mite Extract did not include sufficent numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experiences has not identified differences in responses between the 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 concomitant disease or other drug therapy including beta blockers.

2 Pregnancy: No human or animal data. Use only if clearly needed (8.1) Autoimmune Disease: Immunotherapy may exacerbate the autoimmune disease. Use only if clearly needed (5.3) See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2013

🆘 Overdosage 121 words ▾

10 OVERDOSAGE For all allergenic extracts the therapeutic dose varies per indiviual. If a dose exceeds the window for a particular patient this may be considered an overdose and the patient may experience anaphylaxis. Systemic reactions are uncommon after injection, but if the patient receives more extract than can be tolerated at that particular time, and begins to experience immediate hypersensitivity anaphylaxis, institute emergency treatment by trained personnel.

Overdosage may occur because of an error in the volume of extract or incorrect diluents injected. An overdose may also occur when, in addition to immunotherapy, the patient is exposed concomitantly to similar environmental allergens. In the event of a systemic reaction, the preparation of allergen and dosage schedule should be carefully reviewed.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY Dust mites belonging to the genus Dermatophagoides are indoor allergens found in humid geographic locations worldwide. D. farinae and D. pteronyssinus occur widely with most homes in the United States coinhabited by both species. 11

12.1Mechanism of Action The complete mechanisms of allergen immunotherapy are not clear and remain the subject of investigation. The allergic reaction is dependent on the presence of allergen-specific immunoglobulin E (IgE) antibodies that are bound to specific receptors on mast cells and basophils. The presence of IgE antibodies sensitizes these cells, and upon interaction with the appropriate allergens, histamine and other mediators are released which produce local or systemic responses in sensitive individuals, and characteristic symptoms of atopic diseases, such as allergic rhinitis and allergic asthma.

Changes in serum antibody and T-lymphocyte responses resulting from immunotherapy have been demonstrated, and these changes often correlate closely with clinical (symptom) improvements. Specific mechanisms may vary depending on the nature of the allergic disease, the allergenic specificities of patients and populations, extract formulations, route of administration, dose and duration of treatment. 2 Subcutaneous administration of allergenic extracts is known to elicit numerous immunological changes that are both time and dose-dependent.

Many of these changes appear to be related to (or a precursor to) improvements in symptoms and other clinical parameters, as noted above. Specific changes found after immunotherapy with dust mite extracts include significant increases in mite-specific IgG4 antibodies 12 , interleukin-10-positive T cells, and several T-cell receptors, and significant decreases in serum nitric oxide, eosinophil catonic protein, interleukin-4-positive T cells and IgE-mediated basophil histamine release. 13

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Mite extracts in 50% Glycero-Coca solution are supplied as follows: D. farinae : NDC 22840-0033 5,000 Allergy Units/mL, 10, 30, and 50 mL vials D. farinae : NDC 22840-0034 10,000 Allergy Units/mL, 5 mL percutaneous test vial D. farinae : NDC 22840-0034 10,000 Allergy Units/mL, 10, 30, and 50 mL vials D. pteronyssinus : NDC 22840-0035 5,000 Allergy Units/mL, 10, 30, and 50 mL vials D. pteronyssinus : NDC 22840-0036 10,000 Allergy Units/mL, 5 mL percutaneous test vial D. pteronyssinus : NDC 22840-0036 10,000 Allergy Units/mL, 10, 30, and 50 mL vials D. farinae / D. pteronyssinus mixture: NDC 22840-0037 5,000 Allergy Units/mL each species, 5 mL percutaneous test vial D. farinae / D. pteronyssinus mixture: NDC 22840-0037 5,000 Allergy Units/mL each species, 10, 30, and 50 mL vials D. farinae : NDC 22840-0038 30,000 Allergy Units/mL, 10, 30, and 50 mL vials D. pteronyssinus : NDC 22840-0039 30,000 Allergy Units/mL, 10, 30, and 50 mL vials D. farinae / D. pteronyssinus mixture: NDC 22840-0040 15,000 Allergy Units/mL each species, 10, 30, and 50 mL vials

16.2Storage and Handling Store dust mite extract at 2 to 8°C (36 to 46°F). Keep dust mite extract at 2 to 8°C (36 to 46°F) during office use. Dilutions of concentrated extract result in a glycerin content of less than 50% which results in reduced stability of the extracts.

1:100 dilutions should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known mite allergic individual.

📋 Description 183 words ▾

11 DESCRIPTION Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus ), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.

For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies.

The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL.

The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.

🔬 Clinical Studies 108 words ▾

14 CLINICAL STUDIES The dust mites D. farinae and D. pteronyssinus are the major source of allergens in house dust. 14 The efficacy of immunotherapy for Type I hypersensitivity (i.e. allergy) to airborne allergens 2,15,16 including dust mite has been well established. Specifically, immunotherapy for allergic hypersensitivity to house dust mite allergens has been addressed in a 1995 Cochrane meta-analysis of 20 randomized, controlled trials of immunotherapy, 17 and two subsequent updated Cochrane meta-analysis published in 1999 18 and 2003 19 .

In addition, efficacy for immunotherapy in rush or cluster protocols, in which the dose escalation is compressed over days or weeks, has also been demonstrated. 20,21

🧪 Nonclinical Toxicology 25 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis or Impairment of Fertility No studies in animals have been performed to evaluate carcinogenecity, mutagenicity or impairment of fertility.

📚 References ~2 min read ▾

15 REFERENCES Bernstein IL, Li JT, Bernstein Dl, et al. Allergy dignostic testing: and updated practice parameter. Ann Allergy Asthma Immunol 2008;100:S1-148.

Bernstein IL, Li JT, Bernstein Dl, et al. Allergy dignostic testing: and updated practice parameter. Ann Allergy Asthma Immunol 2008;100:S1-148.

Amin HS, Liss GM, Bernstein Dl. Evaluation of near-fatal reactions to allergen immunotherapy injections. J Allergy Clin Immunol 2006;117:169-75.

Lockey RF, Benedict LM, Turkeltaub PC, Bukantz SC. Fatalities from immunotherapy (IT) and skin testing (ST). J Allergy Clin Immunol 1987;79:660-77.

Reid MJ, Lockey RF, Turkeltaub PC, Platts-Mills TA. Survey of fatalities from skin testing and immunotherapy 1985-1989. J Allergy Clin Immunol 1993;92:6-15.

Bernstein DI, Wanner M, Borish L, Liss GM. Twelve-year survey of fatal reactions to allergen injections and skin testing: 1990-2001. J Allergy Clin Immunol 2004;113:1129-36.

Lockey RF, Nicoara-Kasti GL, Theodoropoulos DS, Bukantz SC. Systemic reactions and fatalities associated with allergen immunotherapy. Ann Allergy Asthma Immunol 2001;87(suppl 1):47-55.

Malling HJ. Minimising the risks of allergen-specific injection immunothreapy. Drug Saf 2000;23:323-332.

Greenberg MA, Kaufman CR, Gonzalez GE, et. al. Late and immediate systemic-allergic reactions to inhalant allergen immunotherapy. J Allergy Clin Immunol 1986;77:865-870.

Jacobs RL, Rake GW, Jr., Fournier DC, Chilton RJ, Culver WG, Beckmann CH. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J Allergy Clin Immunol 1981;68:125-7.

Arlian L, Bernstein D, Bernstein L, et al. Prevalence of dust mites in the homes of people with asthma living in eight different geopgraphic areas of the United States. J Allergy Clin Immunol 1992;90:292-300.

Chapman MD, Platts-Mills TA, Gabriel M, et al. Antibody response following prolonged hyposensitization with Dermatophagoides pteronyssinus extract. Arch Allergy Appl Immunol 1980;61:431-40.

Gurka G, Rocklin R. Immunologic responses during allergen-specific immunotherapy for respiratory allergy. Ann Allergy 1988;61:239-45.

Voorhorst R, Spieksma FTM, Varekamp H. House Dust Atopy and the House Dust Mite. Leiden: Stafleu's Scientific Publishing Co; 1969.

Maunsell K, Wraith DG, Hughes AM. Hyposensitisation in mite asthma. Lancet 1971;1:967-8.

Mite Allergy Subcommittee of the Research Committee of the British Thoracic Association. A trial of house dust mite extract in bronchial asthma. Br J Dis Chest 1979;73:260-70.

Abramson MJ, Puy RM, Weiner JM. Is allergen immunotherapy effective in asthma? A meta-analysis of randomized controlled trials.

Am J Respir Crit Care Med 1995; 151:969-74. Abramson M, Puy R, Weiner J. Immunotherapy in asthma: an updated systematic review.

Allergy 1999;54:1022-41. Abramson MJ, Puy RM, Weiner JM. Allergen immunotherapy for asthma.

The Cochrane Database of Systematic Reviews 2003;CD001186. Bousquet J, Calvayrac P, Guerin B, et al. Immunotherapy with a standardized Dermatophagoides pteronyssinus extract.

I. In vivo and in vitro parameters after a short course of treatment. J Allergy Clin Immunol 1985;76:734-44.

Garcia-Ortega P, Merelo A, Marrugat J, Richart C. Decrease of skin and bronchial sensitization following short-intensive scheduled immunotherapy in mite-allergic asthma. Chest 1993;103:183-7.

📄 Package Label / Principal Display Panel 24 words ▾

0033-6_Std Mite DF_5000_AU 0034-3_Std Mite DF_10000_AU 0035-9_Std Mite DP_5000_AU 0036-6_Std Mite DP_10000_AU 0037-3_Std Mite Mix_5000_AU 0038-9_Std Mite DF_30000_AU 0039-6_Std Mite DP_30000_AU 0040-9_Std Mite Mix_15000_AU

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dermatophagoides farinae — the ingredient across all brands.

Top reported reactions

Anaphylactic Reaction22
Urticaria15
Pruritus12
Wheezing12
Dyspnoea11
Injection Site Reaction10
Dizziness9

Age at onset

Adolescent1
Adult2

Reporter sex

0 reports
Male · 35%
Female · 65%

Serious outcomes

Hospitalization10
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 19 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Greer Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 10 ml (22840-0034-06), 30 ml (22840-0034-08), 50 ml (22840-0034-09). 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?
Greer Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 22840-0033-06 · Greer 22840-0035-06 · Greer →
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.