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Histamine Positive Skin Test Control histamine phosphate 2.75 mg/mL Solution, 5 mL — NDC 00268-0247-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Histamine Positive Skin Test Control histamine phosphate 2.75 mg/mL Solution, 5 mL — NDC 0268-0247-05 (Billing 00268-0247-05)

by ALK-Abello, Inc. · 5 mL in 1 VIAL, MULTI-DOSE

This is a package of 5 mL of Histamine Positive Skin Test Control histamine phosphate 2.75 mg/mL Solution from ALK-Abello, Inc., marketed since Oct 1989 and currently FDA-listed. It is this product's only package size.

NDC 00268-0247-05
🏷️ FDA NDC (as labeled) 0268-0247-05 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

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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 0268-0247-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0268 labeler · 0247 product · 05 package
Package marketed since
Oct 23, 1989
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
5 mL per package
Barcode (UPC-A, from the NDC)
3 0268024705 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0268-0247-05
Product NDC 0268-0247
11-digit billing NDC 00268024705
NCPDP billing unit ML — per mL (volume)
UNII QWB37T4WZZ
Application # BLA103754
SPL Set ID 1159c24c-d9ce-49a2-b0bd-dc27c710f146
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1989-10-23
Route PERCUTANEOUS
Dosage form SOLUTION
Substance HISTAMINE PHOSPHATE
Biologic (Purple Book) 351(a)

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

GPI-14 94200050102010
GPI class Histatrol
GCN Seq No 011576
GCN 45881
HICL code 004477
Ingredient (HICL) Histamine Phosphate
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z1
Therapeutic class — intermediate (HIC2) Positive Effects On Wide-Spread Tissue
HIC3 code Z1A
Therapeutic class — specific (HIC3) Histamine Preparations
AHFS code 36:00.00.00
AHFS class Diagnostic Agents
FDB label name HISTATROL PERCUTANEOUS 1 MG/ML
FDB brand name Histatrol Percutaneous
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 011576
  • GCN: 45881
  • GPI-14 (Medi-Span): 94200050102010
  • HICL (First Databank): 004477
  • AHFS class code: 36:00.00.00
Why two NDCs? The FDA registers this code as 0268-0247-05 — 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 → 00268-0247-05. 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.

Clinical

Label name HISTATROL PERCUTANEOUS 1 MG/ML Ingredient Histamine Phosphate

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.
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
00268-0247-05 You're viewing this Main listing 5 mL in 1 VIAL, MULTI-DOSE 1989-10-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Histamine Positive Skin Test Control 2.75 mg/mLthis 00268-0247-05 ALK-Abello, 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

🏛️
1950
First FDA approval
Sep 1950
📍
2026
Currently FDA-listed
76 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.

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

LabelerALK-Abello, Inc.
FDA applicationBLA103754 (BLA)
Labeler code00268
First marketedOct 1989
Product typeHuman Prescription Drug
Portfolio411 products on file

More NDCs from ALK-Abello, Inc. labeler code 00268

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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

INDICATIONS AND USAGE For use as a positive control in evaluation of allergenic (immediate hypersensitivity or "Type I") skin testing.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For Prick, Puncture and Scratch Testing Histamine base 1 mg/mL (Histamine Phosphate 2.75 mg/mL) should be used to give a reaction. (Refer to Interpretation Section.) Prick, Puncture or Scratch Test Techniques The skin in the test area should be cleansed with alcohol and air dried.

The histamine control skin test solution should be placed at the same site with the other skin test antigens, either on the patient's back or on the volar surface of the forearm. The patient should be placed in a comfortable position before the testing is begun. For the prick test, a sharp needle is used to puncture the skin, but not to draw blood.

If the scratch test is used, carefully break or scratch the skin with a sterile scarifier. Do not draw blood. Each scratch should be about 2 mm - 4 mm in length.

A small drop of the histamine base 1 mg/mL (Histamine Phosphate 2.75 mg/mL) is placed on the abraded skin site no closer than 4 or 5 cm from an adjacent test site. Some physicians prefer to place the solution on the test area and then prick through the drop with a sharp needle. Use a separate sterile scarifier or needle for each patient.

The test should be read at 15 minutes; if a large wheal reaction occurs before that time the test site should be wiped free of histamine. Interpretation The patient's response is based on the size of: erythema (degree of redness) and/or size of wheal (smooth, slightly elevated area) which appear after 10 minutes. For percutaneous testing, different devices and/or techniques influence the size of the reaction.

Therefore, it is important to refer to the device manufacturer's or distributor's instructions when grading reactions. For prick, puncture and scratch testing, histamine base 1 mg/mL (Histamine Phosphate 2.75 mg/mL) should be used to give a positive reaction. In a large population, the NHANES II survey reports a mean diameter (average of length and width) wheal of 4.4 mm ± 1.65 mm (± standard deviation) and a mean erythema of 18.4 mm ± 8.55 mm (± standard deviation) when using 25 gauge B-D needle by prick puncture (Pepys) technique.

7 All positive reactions should be interpreted against an appropriate negative control. For Intradermal Skin Testing Histamine base 0.1 mg/mL (Histamine Phosphate 0.275 mg/mL) or 0.01 mg/mL should be used to give a reaction. (Refer to Interpretation Section.) Intracutaneously (Intradermal) Test Techniques The skin should be cleansed with alcohol and air dried.

A sterile one milliliter tuberculin syringe with 26 or 27 gauge needle should be used. A single sterile syringe should be used for each solution to assure sterility. Only the histamine base 0.1 mg/mL (Histamine Phosphate, 0.275 mg/mL) or greater dilution solution should be used.

The histamine base skin test solution should be injected at the same site with the other skin test allergens, either on the patient's back or on the arm. The patient should be placed in a comfortable position before the testing is begun. The skin is held tense and the needle is inserted almost parallel to the skin, bevel side up, far enough to cover the beveled portion.

Slowly inject 0.01 mL or 0.02 mL, making a small bleb approximately 3 mm - 5 mm in diameter. The test should be read in 15 minutes. Interpretation The patient's response is based on the size of: erythema (degree of redness) and/or size of wheal (smooth, slightly elevated area) which appear after 10 minutes.

For intradermal skin testing, histamine base 0.1 mg/mL (Histamine Phosphate 0.275 mg/mL) or 0.01 mg/mL should be used to give a positive reaction. The available 0.1 mg/mL concentration must be diluted ten-fold to achieve this dose. All positive reactions should be interpreted against an appropriate negative control.

In two successive years of testing, the Committee on Standardization of the American… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 39 words ▾

CONTRAINDICATIONS Histamine should not be injected into individuals with hypotension, severe hypertension, severe cardiac, pulmonary, or renal disease. Not to be used for diagnosis of pheochromocytoma or to test the ability of the gastric mucosa to secrete hydrochloric acid.

⚠️ Warnings 86 words ▾

WARNINGS Care must be taken in intracutaneous testing to avoid injection into a venule or capillary. Pull back gently on the syringe plunger and note if blood is drawn. If blood is drawn, withdraw needle and inject into another skin site.

Small doses by any route of administration may precipitate asthma in patients with bronchial hyperactivity. This product is not intended for inhalation, or subcutaneous injection. The utmost caution is advised in using histamine in such patients and in those with a history of bronchial asthma.

🤒 Adverse Reactions 76 words ▾

ADVERSE REACTIONS Local: Reactions such as wheal, erythema and localized pruritus are to be expected, but if very large (i.e. greater than 4+ as described dosage and administration) may be the first manifestation of a systemic reaction. Systemic: Following the injection of large doses of histamine, systemic reactions may include flushing, dizziness, headache, bronchial constriction, urticaria, asthma, marked hypertension or hypotension, abdominal cramps, vomiting, metallic taste, and local or generalized allergic manifestations (see also OVERDOSAGE ).

🔄 Drug Interactions 167 words ▾

Drug Interactions Drugs can interfere with the performance of skin tests in general, and specifically with histamine 1 . Antihistamines: Response to histamine is suppressed by antihistamines. The length of suppression varies, and is dependent on individual patient, type of antihistamine and length of time the patient has been on antihistamines.

The duration of this suppression may be as little as 24 hours (chlorpheniramine), and can be as long as 40 days (astemizole). Tricyclic Antidepressants: These exert a potent and sustained decrease of skin reactivity to histamine, which may last for a few weeks. Beta 2 Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal.

Theoretically, this may also reduce whealing capacity to histamine. Dopamine: Intravenous infusion of dopamine has been shown to inhibit skin test responses to histamine. Beta Blocking Agents: Propranolol can significantly increase skin test reactivity, including histamine.

Other Drugs: Short acting steroids, inhaled beta agonists, theophylline and cromolyn do not seem to affect skin test response.

🤰 Pregnancy 81 words ▾

Pregnancy Category C It is not known whether Histamine can cause fetal harm when administered during pregnancy or whether it can affect reproduction capacity. Histamine should be given during pregnancy only if clearly needed. There are no adequate and well-controlled studies during pregnancy.

However, based on histamine's known ability to contract uterine muscle, exposure or repeated doses should be avoided. HISTATROL ® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus or mother.

🧒 Pediatric Use 86 words ▾

Pediatric Use Histamine solutions for percutaneous testing have been given safely in infants and young children. 2,3,4,5 Neonates and infants have lower skin test reactivity to histamines as well as common allergens. 3,4,5,6 About 20% of infants less than six months of age have been observed to have a negative reaction to histamine hydrochloride (1 mg/mL of salt).

4 Skin test reactivity gradually increases to age six and plateaus to age sixty. 2,3 Therefore, small skin test reactions should be anticipated in children under age six.

🆘 Overdosage 81 words ▾

OVERDOSAGE A large subcutaneous dose of Histamine Phosphate may cause severe occipital headache, blurred vision, anginal pain, a rapid drop in blood pressure, and cyanosis of the face. Overdosage may cause severe symptoms including vasomotor collapse, shock, and even death. Epinephrine Injection 0.01 mg/kg to a maximum of 1.0 mg given subcutaneously or intramuscularly should be used in case of emergency due to severe reactions (see Precautions ).

An antihistamine preparation may be given intramuscularly to ameliorate systemic reaction to overdose.

🧬 Clinical Pharmacology 119 words ▾

CLINICAL PHARMACOLOGY Histamine acts as a potent vasodilator when released from mast cells during an allergic reaction. It is largely responsible for the immediate skin test reaction of a sensitive patient when challenged with an offending allergen. The effect of added Glycerin (50% v/v) to 1 mg/mL histamine base was studied by puncture testing using a bifurcated needle in twelve volunteer subjects.

The mean sum of cross-diameters of the wheals was 13.25 mm (range 10-15 mm) for the non-glycerinated, and 12.54 mm (range 9-15 mm) for the glycerinated formulation. Sum of cross-diameters of erythema was 52.88 mm (range 23-92 mm) for the non-glycerinated, and 54.42 mm (range 19-87 mm) for the glycerinated formulation. These differences are not statistically significant.

📦 How Supplied / Storage and Handling 49 words ▾

HOW SUPPLIED Multidose vials containing 5 mL histamine base, 1 mg/mL (Histamine Phosphate 2.75 mg/mL) in Glycerin 50% (v/v) for prick, puncture, or scratch testing. Multidose vials containing 5 mL histamine base, 0.1 mg/mL (Histamine Phosphate 0.275 mg/mL) in aqueous solution for intradermal testing. Store at 2° - 8°C.

📋 Description 105 words ▾

DESCRIPTION The chemical formula for Histamine Phosphate is C 5 H 9 N 3 · 2H 3 PO 4 ; its molecular weight is 307.14. For prick, puncture or scratch testing, the product is a sterile solution that contains 1 mg/mL histamine base (2.75 mg/mL Histamine Phosphate) in Water for Injection; it also contains Glycerin 50% (v/v) as viscosity agent and Phenol 0.4% as preservative. For intracutaneous (intradermal) skin testing, the product is a sterile solution that contains 0.1 mg/mL histamine base (0.275 mg/mL Histamine Phosphate) in Water for Injection and Phenol 0.4% as preservative.

The product should be stored refrigerated and protected from light.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General A separate sterile needle or other percutaneous testing device should be used for each individual patient to prevent transmission of hepatitis and other infectious agents from one person to another. Epinephrine Injection (1:1,000) and injectable antihistamines should be available for immediate use in the event the patient exhibits a severe response. A tourniquet can be applied above the test site to slow absorption if a severe response occurs.

Drug Interactions Drugs can interfere with the performance of skin tests in general, and specifically with histamine 1 . Antihistamines: Response to histamine is suppressed by antihistamines. The length of suppression varies, and is dependent on individual patient, type of antihistamine and length of time the patient has been on antihistamines.

The duration of this suppression may be as little as 24 hours (chlorpheniramine), and can be as long as 40 days (astemizole). Tricyclic Antidepressants: These exert a potent and sustained decrease of skin reactivity to histamine, which may last for a few weeks. Beta 2 Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal.

Theoretically, this may also reduce whealing capacity to histamine. Dopamine: Intravenous infusion of dopamine has been shown to inhibit skin test responses to histamine. Beta Blocking Agents: Propranolol can significantly increase skin test reactivity, including histamine.

Other Drugs: Short acting steroids, inhaled beta agonists, theophylline and cromolyn do not seem to affect skin test response. Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted with Histamine. Nursing Mothers It is not known if Histamine administered percutaneously or intracutaneously appears in human milk.

Because many drugs are excreted in human milk, caution should be exercised when histamine is administered to a nursing woman. Pregnancy Category C It is not known whether Histamine can cause fetal harm when administered during pregnancy or whether it can affect reproduction capacity. Histamine should be given during pregnancy only if clearly needed.

There are no adequate and well-controlled studies during pregnancy. However, based on histamine's known ability to contract uterine muscle, exposure or repeated doses should be avoided. HISTATROL ® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus or mother.

Pediatric Use Histamine solutions for percutaneous testing have been given safely in infants and young children. 2,3,4,5 Neonates and infants have lower skin test reactivity to histamines as well as common allergens. 3,4,5,6 About 20% of infants less than six months of age have been observed to have a negative reaction to histamine hydrochloride (1 mg/mL of salt).

4 Skin test reactivity gradually increases to age six and plateaus to age sixty. 2,3 Therefore, small skin test reactions should be anticipated in children under age six.

🍼 Nursing Mothers 36 words ▾

Nursing Mothers It is not known if Histamine administered percutaneously or intracutaneously appears in human milk. Because many drugs are excreted in human milk, caution should be exercised when histamine is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 13 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted with Histamine.

📚 References 215 words ▾

REFERENCES Bousquet, J.: In vivo methods for the study of allergy: skin test, techniques, and interpretation. In Allergy Principles and Practice, 3rd Edition, Middleton, et al eds., C.V. Mosby, St.

Louis, MO, 1988. Skassa-Brociek, W., et al: Skin test reactivity to histamine from infancy to old age. J.

Allergy Clin. Immunol . 80 :711, 1987.

Menardo, J.L., et al: Skin test reactivity in infancy. J. Allergy Clin.

Immunol . 75 :646, 1985. Van Asperen, P.P., et al: Skin test reactivity and clinical allergen sensitivity in infancy.

J . Allergy Clin. Immunol .

73 :381, 1984. Matheson, A., et al: Reactivity of the skin of the newborn infant. Pediatrics 10 :181, 1952.

Stevenson, D.D., et al: Development of IgE in newborn human infants. J. Allergy 48 :61, 1971.

National Center for Health Statistics, P.J. Gergen and P.C. Turkeltaub: Percutaneous immediate hypersensitivity to eight allergens, United States, 1976-80.

Vital and Health Statistics. Series 11, No. 235.

DHHS Pub. No. (PHS) 86-1685.

Public Health Service. Washington. U.S.

Government Printing Office, July 1986. Committee on Standardization. Report of the Committee on Standardization: 1.

A method of evaluating skin test response. Ann. Allergy 29 :30-34, 1971.

Revision: October 2008 © Alk-Abello, Inc., 2008 No. 107K Distributed in Canada by: ALK-Abelló Pharmaceuticals, Inc. #35-151 Brunel Road Mississauga, Ontario Canada L4Z 2H6

📄 Package Label / Principal Display Panel 84 words ▾

PRINCIPAL DISPLAY PANEL POSITIVE SKIN TEST CONTROL-HISTAMINE 5mL sterile multiple dose vial FOR INTRADERMAL TESTING ONLY HISTATROL® HISTAMINE BASE 0.1 mg/mL PRINCIPAL DISPLAY PANEL POSITIVE SKIN TEST CONTROL-HISTAMINE 5mL sterile multiple dose vial FOR INTRADERMAL TESTING ONLY HISTATROL® HISTAMINE BASE 0.1 mg/mL

PRINCIPAL DISPLAY PANEL POSITIVE SKIN TEST CONTROL-HISTAMINE 5mL sterile multiple dose vial FOR PERCUTANEOUS TESTING ONLY HISTATROL® HISTAMINE BASE 1 mg/mL PRINCIPAL DISPLAY PANEL POSITIVE SKIN TEST CONTROL-HISTAMINE 5mL sterile multiple dose vial FOR PERCUTANEOUS TESTING ONLY HISTATROL® HISTAMINE BASE 1 mg/mL

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 Histamine Positive Skin Test Control (this brand).

Top reported reactions

False Negative Investigation Result54
Anaphylactic Reaction7
Skin Test Positive4
Skin Wound4
Erythema3
Hypersensitivity2
Injection Site Pain2

Age at onset

Adult1

Reporter sex

86 reports
Male · 32%
Female · 68%

Serious outcomes

Hospitalization5
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 22 6
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) — 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 — 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 ALK-Abello, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ALK-Abello, 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.
← 00264-9872-10 · B. 00268-0248-05 · ALK-Abello, →
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.