NDC 0006-5424 Antivenin
Latrodectus Mactans Kit

Product Information

What is NDC 0006-5424?

The NDC code 0006-5424 is assigned by the FDA to the product Antivenin which is a plasma derivative product labeled by Merck Sharp & Dohme Llc. The generic name of Antivenin is latrodectus mactans. The product's dosage form is kit and is administered via form. The product is distributed in a single package with assigned NDC code 0006-5424-02 1 kit in 1 carton * 2.5 ml in 1 vial (0006-4084-01) * 1 ml in 1 vial (0006-9011-00). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0006-5424
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Latrodectus Mactans
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Plasma Derivative
Dosage FormKit - A packaged collection of related material.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Merck Sharp & Dohme Llc
Labeler Code0006
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
NDC Code Structure

What are the uses for Antivenin?

Product Characteristics


Product Packages

NDC Code 0006-5424-02

Package Description: 1 KIT in 1 CARTON * 2.5 mL in 1 VIAL (0006-4084-01) * 1 mL in 1 VIAL (0006-9011-00)

Product Details

Antivenin Active Ingredients UNII Codes


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Antivenin Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

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Antivenin Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents


Antivenin (Latrodectus mactans) is a sterile, non-pyrogenic preparation derived by drying a frozen solution of specific venom-neutralizing globulins obtained from the blood serum of healthy horses immunized against venom of black widow spiders (Latrodectus mactans). It is standardized by biological assay on mice, in terms of one dose of Antivenin neutralizing the venom in not less than 6000 mouse LD50 of Latrodectus mactans. Thimerosal (mercury derivative) 1:10,000 is added as a preservative. When constituted as specified, it is opalescent, ranging in color from light (straw) to very dark (iced tea), and contains not more than 20.0 percent of solids.

Each single-dose vial contains not less than 6000 Antivenin units. One unit of Antivenin will neutralize one average mouse lethal dose of black widow spider venom when the Antivenin and the venom are injected simultaneously in mice under suitable conditions.

Clinical Pharmacology

The pharmacological mode of action is unknown and metabolic and pharmacokinetic data in humans are unavailable.

Indications And Usage

Antivenin (Latrodectus mactans) is used to treat patients with symptoms due to bites by the black widow spider (Latrodectus mactans). Early use of the Antivenin is emphasized for prompt relief.

Local muscular cramps begin from 15 minutes to several hours after the bite which usually produces a sharp pain similar to that caused by puncture with a needle. The exact sequence of symptoms depends somewhat on the location of the bite. The venom acts on the myoneural junctions or on the nerve endings, causing an ascending motor paralysis or destruction of the peripheral nerve endings. The groups of muscles most frequently affected at first are those of the thigh, shoulder, and back. After a varying length of time, the pain becomes more severe, spreading to the abdomen, and weakness and tremor usually develop. The abdominal muscles assume a boardlike rigidity, but tenderness is slight. Respiration is thoracic. The patient is restless and anxious. Feeble pulse, cold, clammy skin, labored breathing and speech, light stupor, and delirium may occur. Convulsions also may occur, particularly in small children. The temperature may be normal or slightly elevated. Urinary retention, shock, cyanosis, nausea and vomiting, insomnia, and cold sweats also have been reported. The syndrome following the bite of the black widow spider may be confused easily with any medical or surgical condition with acute abdominal symptoms.

The symptoms of black widow spider bite increase in severity for several hours, perhaps a day, and then very slowly become less severe, gradually passing off in the course of two or three days except in fatal cases. Residual symptoms such as general weakness, tingling, nervousness, and transient muscle spasm may persist for weeks or months after recovery from the acute stage.

If possible, the patient should be hospitalized. Other additional measures giving greatest relief are prolonged warm baths and intravenous injection of 10 mL of 10 percent solution of calcium gluconate repeated as necessary to control muscle pain. Morphine also may be required to control pain. Barbiturates may be used for extreme restlessness. However, as the venom is a neurotoxin, it can cause respiratory paralysis. This must be borne in mind when considering use of morphine or a barbiturate. Adrenocorticosteroids have been used with varying degrees of success. Supportive therapy is indicated by the condition of the patient. Local treatment of the site of the bite is of no value. Nothing is gained by applying a tourniquet or by attempting to remove venom from the site of the bite by incision and suction.

In otherwise healthy individuals between the ages of 16 and 60, the use of Antivenin may be deferred and treatment with muscle relaxants may be considered.


Prior to treatment with any product prepared from horse serum, a careful review of the patient's history should be taken emphasizing prior exposure to horse serum or any allergies. Serum sickness and even death could result from the use of horse serum in a sensitive patient. A skin or conjunctival test should be performed prior to administration of Antivenin. However, an anaphylactic reaction to Antivenin may occur even following a negative skin or conjunctival test (see ADVERSE REACTIONS).

Skin test: Inject into (not under) the skin not more than 0.02 mL of the test material (1:10 dilution of normal horse serum in physiologic saline). Evaluate result in 10 minutes. A positive reaction is an urticarial wheal surrounded by a zone of erythema. A control test using Sodium Chloride Injection facilitates interpretation of the results.

Conjunctival test: For adults instill into the conjunctival sac one drop of a 1:10 dilution of horse serum and for children one drop of 1:100 dilution. Itching of the eye and reddening of the conjunctiva indicate a positive reaction, usually within 10 minutes.

Patients should be observed for serum sickness for an average of 8 to 12 days following administration of Antivenin.

Desensitization should be attempted only when the administration of Antivenin is considered necessary to save life. Epinephrine must be available in case of untoward reaction.

Desensitization: If the history is positive or the results of the sensitivity tests are mildly or questionably positive, Antivenin should be administered as follows to reduce the risk of an immediate severe allergic reaction:

  • In separate sterile vials or syringes prepare 1:10 or 1:100 dilutions of Antivenin in Sodium Chloride for Injection.
  • Allow at least 15 but preferably 30 minutes between injections and only proceed with the next dose if no reactions occurred following the previous dose.
  • Using a tuberculin syringe, inject subcutaneously 0.1, 0.2 and 0.5 mL of the 1:100 dilution at 15 or 30 minute intervals; repeat with the 1:10 dilution, and finally the undiluted Antivenin.
  • If there is a reaction after any of the injections, place a tourniquet proximal to the sites of injection and administer epinephrine, 1:1000 (0.3 to 1.0 mL subcutaneously, 0.05 to 0.1 mL intravenously), proximal to the tourniquet or into another extremity. Wait at least 30 minutes before giving another injection of Antivenin, the amount of which should be the same as the last one not evoking a reaction.
  • If no reaction has occurred after 0.5 mL of undiluted Antivenin has been given, it is probably safe to continue the dose at 15 minute intervals until the entire dose has been injected.

Patients With Asthma

Anaphylactic reactions and death have been reported in patients with a medical history of asthma.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long term studies in animals have been performed to evaluate the potential for carcinogenesis, mutagenesis, or impairment of fertility.


Animal reproduction studies have not been conducted with Black Widow Spider Antivenin. It is also not known whether Black Widow Spider Antivenin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Black Widow Spider Antivenin should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Black Widow Spider Antivenin is administered to a nursing woman.

Pediatric Use

Controlled clinical studies for safety and effectiveness in children have not been conducted.

Geriatric Use

Reported clinical experience has not identified differences in responses between the elderly and younger patients. Because of the increased risk of complications from envenomation in elderly patients, the standard of care described in the literature suggests that patients older than 60 years of age should be given Antivenin as a preferred initial therapy (see INDICATIONS AND USAGE).

Adverse Reactions

The following adverse reactions have been reported following the use of Antivenin: Hypersensitivity reactions including anaphylaxis and serum sickness. Muscle cramps have also been reported.

Dosage And Administration

Using a sterile syringe, inject 2.5 mL of Sterile Water for Injection into the single-dose vial of Antivenin. With the needle still in the rubber stopper, shake the vial to dissolve the contents completely.

Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit (see DESCRIPTION).

The dose for adults and children is the entire contents of a restored single-dose vial (2.5 mL) of Antivenin. It may be given intramuscularly, preferably in the region of the anterolateral thigh so that a tourniquet may be applied in the event of a systemic reaction. Symptoms usually subside in 1 to 3 hours. Although one dose of Antivenin usually is adequate, a second dose may be necessary in some cases. Discard unused portion.

Antivenin also may be given intravenously in 10 to 50 mL of saline solution over a 15 minute period. It is the preferred route in severe cases, or when the patient is under 12, or in shock. One restored single-dose vial usually is enough. Discard unused portion.

How Supplied

No. 5424 — Antivenin (Latrodectus mactans), equine origin is a white to gray crystalline powder, each single-dose vial containing not less than 6000 Antivenin units. Thimerosal (mercury derivative) 1:10,000 is added as preservative, NDC 0006-5424-02. A single-dose 1 mL vial of normal horse serum (1:10 dilution) for sensitivity testing is also included. Thimerosal (mercury derivative) 1:10,000 is added as preservative.


Antivenin must be stored and shipped at 2-8°C (36-46°F). When reconstituted as directed, the color of Antivenin ranges from light (straw) to very dark (iced tea), but the color has no effect on potency. Do not freeze.


Barron, W. E.: Spider Bites, J. Med. Ass. Georgia 49: 511-512, Oct. 1960.

Micks, D. W.: Insects and Other Arthropods of Medical Importance in Texas, Tex. Rep. Biol. & Med. 18: 624-635, Winter 1960.

Prince, G. E.: Arachnidism in Children, J. Pediat. 49: 101-108, July 1956.

Russell, F. E.: Injuries by Venomous Animals in the United States, J. Amer. Med. Ass. 177: 903-907, Sept. 30, 1961.

Russell, F. E.: Muscle Relaxants in Black Widow Spider (Latrodectus mactans) Poisoning, Amer. J. Med. Sci. 243: 159-162, Feb. 1962.

Russell, F. E.: Venom Poisoning, Rational Drug Therap. 5: 5-6, Aug. 1971.


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Copyright © 2013-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 02/2020


This Is A Representative Sample Of The Packaging. Please See How Supplied Section For A Complete List Of Available Packaging.Principal Display Panel - Kit Carton

NDC 0006-5424-02

1 Single-dose 2.5 mL Vial


Equine Origin

Rx only

For Intramuscular or Intravenous Use

Manufactured and Distributed by:
Merck Sharp & Dohme Corp., a subsidiary of
Whitehouse Station, NJ 08889, USA

U.S. Govt. Lic. No. 0002 Canadian Lic. No. 2

Copyright © 2013 Merck Sharp & Dohme Corp.,
a subsidiary of Merck & Co., Inc.
All rights reserved.

* Please review the disclaimer below.