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Standardized Cat Hair 10000 [BAU]/mL Injection, 10 mL — NDC 49643-0705-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Standardized Cat Hair 10000 [BAU]/mL Injection, 10 mL — NDC 49643-705-10 (Billing 49643-0705-10)

by Allermed Laboratories, Inc. · 10 mL in 1 VIAL, MULTI-DOSE

This is a package of 10 mL of Standardized Cat Hair 10000 [BAU]/mL Injection from Allermed Laboratories, Inc., marketed since Aug 1992 and currently FDA-listed.

NDC 49643-0705-10
🏷️ FDA NDC (as labeled) 49643-705-10 billing pads the product segment with a zero
This package
Contains10 mL Pack sizes4 compare ↓
Product page 49643-0705-05 Also comes in: 5 ml 49643-705-05 30 ml 49643-705-30 50 ml 49643-705-50
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49643-705-10
Product NDC 49643-705
11-digit billing NDC 49643070510
RxCUI 851948
UNII 1564HD0N96
Application # BLA103473
SPL Set ID abffdafd-f922-44ab-8e98-972a72ca1004
Established class (EPC) Standardized Animal Hair Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Dander; Allergens; Salivary Proteins and Peptides
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1992-08-15
Route CUTANEOUS, INTRADERMAL, SUBCUTANEOUS
Dosage form INJECTION
Substance FELIS CATUS HAIR
Biologic (Purple Book) 351(a)
Quick answers
  • RxCUI (RxNorm): 851948
Why two NDCs? The FDA registers this code as 49643-705-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 49643-0705-10. 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 Animal Hair Allergenic Extract class.

Pharmacologic class Standardized Animal Hair 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 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: 5 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
49643-0705-05 49643-705-05 Main listing 5 mL in 1 VIAL, MULTI-DOSE 1992-08-15 — Active
49643-0705-10 You're viewing this 10 mL in 1 VIAL, MULTI-DOSE 1992-08-15 — Active
49643-0705-30 49643-705-30 30 mL in 1 VIAL, MULTI-DOSE 1992-08-15 — Active
49643-0705-50 49643-705-50 50 mL in 1 VIAL, MULTI-DOSE 1992-08-15 — Active

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

Pack size FAQ

What quantity is in this package?
This package contains 10 mL — 10 ml in 1 vial, multi-dose.
How does this package differ from NDC 49643-0705-05?
Both are Standardized Cat Hair 10000 [BAU]/mL Injection — the drug itself is identical. This page's package is the 10 mL one, while NDC 49643-0705-05 is the 5 ml package.
What NDC number is used to bill for this package of Standardized Cat Hair 10000 [BAU]/mL Injection?
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
Cat Hair, Standardized 10000 [BAU]/mL 00268-2000-10 ALK-Abello, 10 ml — — FDA listed —
Cat Hair, Standardized 10000 [BAU]/mL 00268-2001-06 ALK-Abello, 5 ml — — FDA listed —
Standardized Cat Hair 10000 [BAU]/mLthis 49643-0705-10 Allermed 10 ml — — FDA listed —
Standardized Cat Hair 10000 [BAU]/mL 65044-4815-01 Jubilant 5 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

🏛️
1974
First FDA approval
Mar 1974
📍
2026
Currently FDA-listed
52 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.

  • 0.53 mL / 1 mL 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.
  • 0.004 g / 1 mL 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.
  • 0.00125 g / 1 mL 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.
  • 0.0025 g / 1 mL 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 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

LabelerAllermed Laboratories, Inc.
FDA applicationBLA103473 (BLA)
Labeler code49643
First marketedAug 1992
Product typeHuman Prescription Drug
Portfolio199 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNINGS This allergenic product is intended for use 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. Standardized Cat Hair Extract is not directly interchangeable with Standardized Cat Pelt Extract or Cat Extracts labeled in Allergy Units (AU/mL) The initial dose must be based on skin testing as described in the dosage and administration section of this insert. Patients being switched from other types of cat extracts to Standardized Cat Hair Extract should be started as though they were coming under treatment for the first time Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physicians office if reaction symptoms occur.

As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these reactions may result in death. Patients should be observed for at least 20 minutes following treatment and emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction.

This product should not be injected intravenously (see Dosage and Administration). Refer also to the warnings, precautions, adverse reactions and overdosage sections below. Serious adverse reactions to this product should be reported to MEDWATCH, Food and Drug Administration, 5600 Fishers Lane, MD 20852-9787.

Telephone 1-800-822-7967 or www.vaers.hhs.gov.

🎯 Indications and Usage 147 words ▾

INDICATIONS AND USAGE Studies have shown that skin tests with cat extract are useful in the diagnosis of cat allergy. As a rule, persons with cat allergy have positive skin reactions when tested with cat extract, and non-allergic individuals rarely react (7, 8, 9). However, the relationship between a positive skin test and the appearance of clinical symptoms after exposure to a cat is not absolute, i.e., some skin-test positive persons do not experience allergic symptoms after exposure (10).

Failure to experience symptoms may be dose related, since it is known that cats vary significantly in the amount of Fel d1 they produce (11). The efficacy of cat extract immunotherapy in the treatment of bronchial asthma has been shown in two studies (12, 13) A reduction in bronchial sensitivity was observed in five patients with cat allergy, whereas no reduction was observed in placebo treated, cat-allergic patients.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Diagnosis: Concentrated extract (10,000 BAU/mL) may be used for scratch or prick-puncture testing. Puncture tests performed with a bifurcated needle in ten cat allergic persons showed a mean wheal diameter of 6.6 mm (S.D. 1.3) with a mean sum of erythema of 57.3 mm (S.D.

10.4). Intradermal tests with serial three-fold dilution of the 10,000 BAU/mL showed the following results: Serial 3-Fold Dilutions of 10,000 BAU/mL Extract Subject 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 1 X 2 X 3 X 4 X 5 X 6 X 7 X 8 X 9 X 10 X The mean three-fold dilution eliciting a response of 50 mm sum of erythema diameters was 11.120 (S.D. 2,38).

The number of BAU/mL required to elicit this response was 0.05 (range 0.0003 to

9.24BAU/mL). This concentration is approximately a 1:200,000 v/v dilution of the 10,000 BAU/mL extract. Extract for intradermal testing should be used as follows: Patients with a positive scratch or prick test to Standardized Cat Hair Extract.

It is not advisable to perform an intradermal skin test in these patients. Patients with a negative scratch or prick test to Standardized Cat Hair Extract. Patients who do not react to a scratch or prick test with the 10,000 BAU/mL concentrate maybe tested intradermally with 0.05 mL of a 1:2,000 v/v dilution of the concentrate (5 BAU/mL).

If the test is negative, a second test should be performed with 0.05 mL of a 1:200 v/v dilution of concentrate (50 BAU/mL). Patients tested only by the intradermal method with Standardized Cat Hair Extract. Patients suspected of being highly allergic to cats should be tested with 0.05 mL of a 1:200,000 v/v dilution (0.05 BAU/mL) of the concentrate.

A negative test should be followed by repeat tests using 10 fold stronger concentrations until the maximum dose of 0.05 mL of a 1:200 v/v dilution (50 BAU/mL) is reached. Interpretation Of Skin Tests: The interpretation of skin tests should be based on the size of the erythema and wheal response to the allergen compared to a negative saline control. A suggested method of scoring skin tests is shown below.

Measurements refer to the longest (single), diameter of erythema and wheal response. Scratch and Prick Test A negative test shows only a slight red area at the site of scarification or prick penetration. Positive tests are scored as follows: 1 + Erythema with a 5 mm wheal 2 + Erythema with a 5 -10 mm wheal 3 + Erythema with a 10 - 15 mm wheal 4 + Erythema with a wheal 15 mm (or larger) with pseudopodia Intradermal Test A negative test shows no change in the appearance and size of the 5mm wheal created by the 1.D. injection of 0.05 mL of extract.

Positive tests are scored as follows: 1 + Erythema 10 - 20 mm with a 5 -10 mm wheal 2 + Erythema 20 - 30 mm with a 5 -10 mm wheal 3 + Erythema 30 - 40 mm with a 10 - 15 mm wheal 4 + Erythema greater than 40 mm with a 15 mm wheal (or larger) with pseudopodia Immunotherapy Allergenic extract should be administered subcutaneously in the outer aspect of the upper arm using a sterile tuberculin syringe and needle. The skin should be cleaned with 70% alcohol and aseptic technique should be observed in removing the extract from the vial.

Care must be taken to avoid injecting the extract into a blood vessel because of the potential hazard of anaphylaxis. Standardized Cat Hair Extract must be diluted before administration to new patients. As a precaution against overdose, a skin test with the intended starting dose should be done to help evaluate the patient's sensitivity to the product.

If the skin response is larger than 5/15 mm (edema/erythema), the extract should be diluted before it is given subcutaneously. The doses shown in the Dosage Schedule may be followed unless the patient's skin test response and allergic history indicate that more dilute extract should be used. Little is known about the required accumulated dosage of Fel d 1 (and other allergens that may be present in cat extract) that is needed to relieve symptoms.

However, studies with other al… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 29 words ▾

CONTRAINDICATIONS Standardized Cat Hair Extract should not be used for immunotherapy in persons who do not have cat related allergic symptoms and a positive skin test to the extract.

⚠️ Warnings ~1 min read ▾

WARNINGS Standardized Cat Hair Extract may cause local or severe life-threatening reactions when administered to highly sensitive individuals. Physicians who use this product should be familiar with the clinical use of allergenic extract and have the necessary emergency equipment and medications available to treat systematic allergic reactions See Precautions, Adverse Reactions and Overdosage . Standardized Cat Hair Extract should not be used interchangeably with Standardized Cat Pelt Extracts or previously standardized cat extracts labeled in Allergy Units per mL.

Cat hair extracts labeled in BAU/mL made by other manufacturers should be tested for bioequivalency by serial titration skin testing before these products are used in patients who have previously received Allermed Standardized Cat Hair Extract. The dosage of Standardized Cat Hair Extract must be reduced when starting a patient on a new lot of Standardized Cat Hair Extract containing the same amount of Fel d1 units per mL. This is necessary due to a possible loss of potency during storage in the physician's office.

The dose of the new lot of extract should not exceed 1/4 the last dose given from the old lot of extract. Any evidence of a strong local reaction or systemic reaction following the administration of Standardized Cat Hair Extract requires a reduction in dosage during the initial stages of immunotherapy, as well as during maintenance therapy.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Local Reactions From Skin Testing Large local reactions may result from skin tests with Standardized Cat Hair Extract. To help prevent this, a patient should be skin tested initially by the prick or scratch method. If a positive response is NOT observed, an intradermal skin test may be performed with a more dilute solution of the extract.

Oral antihistamines and topical corticosteroids may be administered to relieve itching and swelling resulting from large skin test reactions. Local Reactions From Subcutaneous Injections The occurrence of a hive 5 to 15 minutes after the subcutaneous injection of extract is usually due to leakage of extract into the skin along the needle tract. Firm pressure (not rubbing) at the site of injection immediately after withdrawal of the needle will usually prevent this reaction.

It does not require a reduction in dosage. However, a strong local reaction with erythema and edema which persists at the injection site for several hours indicates that too much extract has been given. Failure to note this response may result in a serious generalized reaction.

Treatment should be altered as follows: Additional injections should not be given until all evidence of the reaction has disappeared. The next injection administered should be 50% of the last nonreacting dose or less, depending upon the size and severity of the local reaction. Subsequent injections should be continued at the reduced dosage unless the physician responsible for treatment believes that it is safe to increase the dose, and that possible clinical improvement would result from the administration of a larger dose of extract.

Systemic Reactions Systemic reactions may range from a mild exacerbation of the patient's allergic symptoms to hives, anaphylactic shock, or even death from anaphylaxis. The reaction usually occurs 5 to 20 minutes after injection. As a rule, the more quickly a reaction develops, the more serious it is likely to become.

Symptoms may include sneezing, coughing, itching, shortness of breath, abdominal cramps, vomiting, diarrhea, tachycardia, hypotension and respiratory failure in severe cases. The reaction is usually stopped by the subcutaneous injection of Epinephrine HCL 1:1,000 (See Overdosage below). The oral administration of antihistamines and the placement of a tourniquet proximal to the injection site are helpful adjuncts.

In the event that additional measures are required, it may be necessary to treat the patient for BRONCHOSPASM with intravenous aminophylline, intravenous fluids and corticosteroids; for HYPOTENSION with vasopressors, volume repletion, isoproterenol and corticosteroids; for LARYNGEAL OBSTRUCTION with oxygen and tracheotomy and for CARDIAC ARREST with cardiopulmonary resuscitation and other appropriate measures.

🆘 Overdosage 101 words ▾

OVERDOSAGE Severe generalized symptoms or anaphylaxis following an injection must be treated immediately with Epinephrine HCL 1:1,000 as follows: Usual Dosage-Infants under 2 years 0.05 to 0.1 cc; children under 12 years 0.1 to 0.2 cc; persons over 12 years 0.3 to 0.5 cc, repeated as necessary every 10 to 15 minutes. Placement of a tourniquet above the site of injection may be helpful in controlling the absorption of the extract. It should be released every 10 minutes and reapplied as needed.

Intravenous antihistamines and hydrocortisone also may be used, but only after sufficient epinephrine has been given (See Adverse Reactions).

🧬 Clinical Pharmacology 66 words ▾

CLINICAL PHARMACOLOGY Positive skin tests with allergenic extract are the result of histamine release from mast cells sensitized with allergen specific IgE. The exact mechanisms by which immunotherapy relieves symptoms of allergy are still under investigation. Elevations in allergen-specific IgG antibodies and an increase in the activity of T suppressor lymphocytes appear to be some of the immunologic changes that occur from hyposensitization (4, 5, 6).

📦 How Supplied / Storage and Handling 35 words ▾

HOW SUPPLIED Standardized Cat Hair Extract containing 10,000 BAU per mL is supplied in 5 mL dropper vials for scratch or prick testing and in 10 mL, 30 mL and 50 mL vials as concentrate.

📦 Storage and Handling 21 words ▾

STORAGE AND HANDLING Extract should be stored at 2°C to 8°C since higher temperatures may adversely affect stability. Do not freeze.

📋 Description ~1 min read ▾

DESCRIPTION Standardized Cat Hair Extract is a clear, light yellow to amber solution of the allergens of cat hair, extracted in buffered saline containing sodium chloride, sodium bicarbonate and 50% glycerol by volume. Phenol at 0.4% w/v is added as a preservative. Source material for the extract is obtained from the hair of the domestic cat The importance of surface allergens in cat allergy has been shown in several investigations (1,2,3).

Standardization The potency of Standardized Cat Hair Extract is based on the amount of Fel d 1 allergen in the extract. Extract containing 5-9.9 units per mL is assigned a potency of 5,000 Bioequivalent Allergy Units (BAU/mL). Extract containing 10-19.9 Fel d 1 units is assigned a potency of 10,000 BAU/mL.

BAU/mL values are based on quantitative skin testing. The primary allergen of Standardized Cat Hair Extract is Fel d 1 . Standardized Cat Pelt Extract contains Fel d 1 , as well as non-Fel d 1 allergens.

The latter are believed lobe components of cat serum, such as albumin. Pelt extracts have a higher protein content than hair extracts, and the isoelectric focusing (IEF) pattern of the pelt extract reveals protein bands that are not present in cat hair extracts. The IEF pattern of cat hair extracts shows primarily Fel d 1 allergen without serum components.

The importance of Fel d1 as a means of standardizing the potency of cat extract is based on the following observations: 1. The intensity of skin reactions to cat extract correlates with the Fel d 1 content of the extract in most cat sensitive patients(1). 2.

The absorption of cat extract with monospecific antisera to Fel d 1 causes a reduction in the allergenic activity of cat extract (1). 3. The precipitin arc of Fel d 1 in cat extract binds most of the IgE antibody in sera obtained from cat allergic individuals (2).

⚠️ Precautions ~2 min read ▾

PRECAUTIONS GENERAL : Do not inject intravenously. After the needle is inserted subcutaneously, the plunger should be withdrawn slightly to check for the presence of blood in the syringe If blood is observed, a new injection should be prepared and given at another site, Observing the same precautions. The extract should be stored at 2°C-8°C.

Dilutions of the 10,000 BAU/mL concentrate should be made with buffered saline containing human serum albumin for maximum stability. However, regardless of diluent type, diluted extract should be checked by skin test on a known cat-allergic individual if loss of potency is suspected. PREGNANCY CATEGORY C : Animal reproduction studies have not been conducted with Standardized Cat Hair Extract .

It is also not known whether allergenic extract can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Standardized Cat Hair Extract should be given to a pregnant woman only if clearly needed. PATIENT INSTRUCTIONS : Patients should be instructed to remain in the physician's office for at least 20 minutes after skin testing and after each treatment injection, and immediately notify the physician if symptoms of a generalized reaction or shock occur.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY : Long term studies have not been conducted with Standardized Cat Hair Extract to determine their potential for carcinogenesis, mutagenesis, and impairment of fertility. NURSING MOTHERS : Data are not available on the secretion of Standardized Cat Hair Extract in human milk and it is not known what effect this might have on the nursing infant. PEDIATRIC USE : The dose of Standardized Cat Hair Extract recommended for children is the same as that used for adults, except in the injection of large doses of extract for treatment.

In this case, the amount of extract given to a child may be modified so that the discomfort of the injection is minimized. DRUG INTERACTION : The skin test response to Standardized Cat Hair Extract in sensitive persons may be suppressed by previous treatment with antihistamines and drugs with antihistamine activity. Treatment with beta-blocking drugs may make patients refractory to the usual dose of epinephrine, in the event epinephrine is required to control an adverse allergic reaction.

Caution should be observed in the following circumstances: EXTREME SENSITIVITY TO CATS : Determined from previous anaphylaxis following skin testing or natural exposure. AUTOIMMUNE DISEASE: Individuals with autoimmune disease may be at risk, due to the possibility of routine immunizations exacerbating symptoms of the underlying disease. MYOCARDIAL INFARCTION: Patients who have experienced a recent myocardial infarction may not be able to tolerate immunotherapy.

As in all of the above circumstances, the benefit to risk ratio must be carefully evaluated Standardized Cat Hair Extract should be temporarily withheld from patients if any of the following conditions exist: (1) severe symptoms of rhinitis and/or asthma; (2) infection or flu accompanied by fever, and (3) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.

📚 References ~1 min read ▾

REFERENCES 1. Ohman, J.L. Studies of the origin and environmental occurrence of cat allergen.

J. Allergy Clin. Immunol., 69:127, 1982.

2. Anderson, M.G., and Baer, H.. Allergenically active components of cat allergen extracts.

J. Immunol., 127:972, 1981. 3.

Spain, W.C., Gillson, R.E. and Strauss, M.B.. Comparative immunologic studies with salivary and epithelial extracts of the dog, cat and rabbit. J.

Allergy., 13:563, 1942. 4. Levy, D.A., Lichtenstein, L.M., Goldstein E.O. and Ishizaka, K..

Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigations.

50:360, 1971. 5. Evans, R., Pence, H., Kaplan, H and Rocklin, R.

The effect of immunotherapy on humoral and cellular response in ragweed hayfever, J. Clinical Investigations. 57:1378, 1976.

6. lshizaka, K. Cellular events in the IgE antibody response. Adv. in Immunology.

23:50, 1976. 7. Muljono.

I.S. and Voorhost, R. Atopy to dander from domestic animals, Allergie Immunol. 24:50, 1978.

8. Curran, W. andGoldman, G. The incidence of immediately reacting allergy skin tests in a normal adult population.

Ann. Internal Med. 55:777, 1961.

9. Fontana, V.J.,Whittig, H. and Holt Jr., L.E. Observations on the specificity of the skin test.

The incidence of positive skin tests in allergic and non-allergic children. J. Allergy.

34:348, 1963. 10. Sarsfield, J.K., Boyle, A.G.

Rowell, E.M. and Moriarty, S.C.. Pet sensitivities in asthmatic children. Arch.

Dis., Childhood. 51:186, 1976. 11.

Ohman, J.L., Baer, H., Anderson, M.C. Leitermann, K. and Brown, P. Surface washes of living cats: An improved method of obtaining clinically relevant allergen.

J. Allergy Clin. Immunol.

72:288, 1983. 12. Taylor, W.W.

Ohman, J.L. and Lowell, F.C. Immunotherapy in cat-induced asthma. Double-blind trial with evaluation of bronchial response to cat allergen and histamine.

J. Allergy Clin. lmmunol. 61:283, 1978.

13. Van Metre, T.E., Marsh, D.G., Adkinson Jr., N.F., Kagey-Sobotka, A., Khattignavong, A., Norman Jr., P.S. and Rosenberg, G.L. Immunotherapy for cat asthma.

J. Allergy Clin. Immunol., 82:1055, 1988.

📄 Package Label / Principal Display Panel 3 words ▾

0705-50_Std Cat Hair_50mL

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

About this NDC listing & data coverage

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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
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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 Allermed 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 5 ml (49643-0705-05), 30 ml (49643-0705-30), 50 ml (49643-0705-50). 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?
Allermed 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.
← 49643-0704-05 · Allermed 49643-0802-04 · Allermed →
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.