![North American Coral Snake Antivenin (Equine) Coral Snake (Micrurus Fulvius) Immune Globulin 250 [arb'U]/10mL Injection, Powder, For Solution — NDC 00008-0423-03 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6d0f94b4-82ca-37c7-edb0-4f0702cf6c8d&name=antivenin-03.jpg)
North American Coral Snake Antivenin (Equine) Coral Snake (Micrurus Fulvius) Immune Globulin 250 [arb'U]/10mL Injection, Powder, For Solution
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 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.
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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.
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UNII 2225PI3MOV
A mercury-containing preservative used to prevent bacterial and fungal contamination in multi-dose vials of vaccines and some injectable medicines. It stops microorganisms from growing in the product during storage and use.
2 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 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 system | Per mL | Per 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. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| North American Coral Snake Antivenin (Equine) 250 [arb'U]/10mLthis 00008-0423-03 | Wyeth | 1 vial | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00008-0423-03 You're viewing this | 1 VIAL in 1 CARTON (0008-0423-03) / 10 mL in 1 VIAL (0008-0423-01) | 2016-10-12 | Active |
🧭 About this NDC listing & data coverage
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. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties). North American Coral Snake Antivenin (Equine) is a horse-derived antivenin indicated for the treatment of envenomation caused by North American coral snakes - Micrurus . ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For intravenous use only. For intravenous use only. • In adults and adolescents, the dose may vary from 3 to 5 vials, depending on the response to treatment. ( 2.1 ) • In small children, the dose may be decreased, depending on the response to treatment.
( 2.1 ) • Contents of each reconstituted vial can neutralize approximately 250 mouse (Lethal Dose) LD 50 or approximately 2 mg of M. fulvius venom. ( 2.1 ) • Infuse the first 1 or 2 mL over a 3- to 5-minute period, observing for allergic reaction. If tolerated, administer the rest of the dose at the rate that is comfortable for the patient based on body weight and general condition.
Do not exceed 4 mL per minute for children. ( 2.2 )
2.1Dose • Contents of each reconstituted vial can neutralize approximately 250 mouse (Lethal Dose) LD 50 or approximately 2 mg of Micrurus fulvius fulvius ( M. f. fulvius) venom. • In adults and adolescents, the dose may vary from 3 to 5 vials, depending on the response to treatment. • In small children, the dose may be decreased, depending on the response to treatment.
2.2Preparation and Administration Preparation • Pry off the small metal disc in the cap over the diaphragms of the vials of North American Coral Snake Antivenin (Equine) and remove cap from diluent vials. • Swab the exposed surface of the rubber diaphragms of both vials with an appropriate germicide. • Withdraw 10 mL diluent (Sterile Water for Injection, USP) using a sterile syringe and needle, and insert the needle through the stopper of the vacuum-containing vial of North American Coral Snake Antivenin (Equine). o The vacuum in the North American Coral Snake Antivenin (Equine) vial will pull the diluent out of the syringe into the vial.
Allow room air to be pulled into the North American Coral Snake Antivenin (Equine) vial until all vacuum is released. o Point the needle at the center of the lyophilized pellet of North American Coral Snake Antivenin (Equine) so that the diluent stream will wet the pellet. • Reconstitute by swirling, not by shaking, for 1 minute, at 5-minute intervals until you observe complete dissolution of the lyophilized North American Coral Snake Antivenin (Equine). Complete reconstitution usually requires at least 30 minutes. Administration • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. • Start an intravenous infusion of 250 to 500 mL of Sodium Chloride Injection, USP. • Determine whether the patient has hypersensitivity to horse-serum in order to evaluate treatment decisions, and to prepare for treatment of anaphylaxis if it occurs [see Warnings and Precautions (5.1) ] . • After reconstitution of the lyophilized North American Coral Snake Antivenin (Equine) administer the contents of 3 to 5 vials (30 to 50 mL) intravenously by slow injection directly into the intravenous tubing or the reservoir bottle of the intravenous solution.
If added to reservoir bottle, mix by gentle swirling – do not shake. • Administer the first 1 or 2 mL over a 3- to 5-minute period with careful observation of the patient for evidence of an allergic reaction. If no signs or symptoms of anaphylaxis appear, continue the injection or intravenous infusion. • Adjust the infusion rate by the severity of signs and symptoms of envenomation and tolerance of North American Coral Snake Antivenin (Equine). Administer at the maximum safe rate for intravenous fluids, based on body weight and general condition of the patient. o For adults, if given by intravenous infusion to a previously healthy adult, allow 250 or 500 mL to run in within 30 minutes; o For small children, allow the first 100 mL to run in rapidly but then decrease to a rate not to exceed 4 mL per minute.
Response to treatment may be rapid and dramatic. • Observe the patient carefully and administer additional North American Coral Snake Antivenin (Equine) intravenously as required.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Each package contains one single use vial with lyophilized North American Coral Snake Antivenin (Equine) for dilution with 10 mL of diluent (Sterile Water for Injection, USP). Contents of each reconstituted vial can neutralize approximately 250 mouse (Lethal Dose) LD 50 or approximately 2 mg of M. f. fulvius venom. Lyophilized powder in single use vial for reconstitution for injection. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Do not administer North American Coral Snake Antivenin (Equine) prophylactically to asymptomatic patients. 1 • Do not administer North American Coral Snake Antivenin (Equine) to patients with a known history of hypersensitivity to horse serum unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available. • Do not administer North American Coral Snake Antivenin (Equine) prophylactically to asymptomatic patients. ( 4 ) • Do not use in patients with a known history of hypersensitivity to horse serum unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Patients sensitive to North American Coral Snake Antivenin (Equine) or horse serum may develop anaphylaxis. Prior to intravenous North American Coral Snake Antivenin (Equine) administration consider performing a proper skin test and modify therapy if indicated. ( 5.1 )
5.1Hypersensitivity Reactions Patients sensitive to North American Coral Snake Antivenin (Equine) or horse serum may develop anaphylaxis. Prior to intravenous North American Coral Snake Antivenin (Equine) administration, consider performing a proper skin test and modify therapy if indicated. Consider the following precautions to manage hypersensitivity reactions: • Emergency medical care (e.g., epinephrine, intravenous antihistamines and/or albuterol) should be readily available. • Carefully monitor patients for signs and symptoms of an acute allergic reaction (e.g., urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, tachycardia). • Follow-up all patients for signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia).
Patients who receive a course of treatment with a foreign protein such as North American Coral Snake Antivenin (Equine) may become sensitized to it. Therefore, use caution when administering a repeat course of treatment with North American Coral Snake Antivenin (Equine) for a subsequent envenomation episode.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions observed after treatment with North American Coral Snake Antivenin (Equine) were anaphylaxis and serum sickness, vomiting, and abdominal pain. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Adverse reactions may include anaphylaxis and serum sickness, vomiting, and abdominal pain.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available human data that establish developmental toxicity related to the use of North American Coral Snake Antivenin (Equine). There are no available animal data informing the North American Coral Snake Antivenin (Equine)-associated risk. North American Coral Snake Antivenin (Equine) should be given to a pregnant woman only if clearly required.
In the US general population, the background risk of major birth defects is 2–4% and of miscarriage is 15–20% in clinically recognized pregnancies.
8.2Lactation Risk Summary Lactation studies have not been conducted with North American Coral Snake Antivenin (Equine). It is not known whether North American Coral Snake Antivenin (Equine) is excreted in human milk. North American Coral Snake Antivenin (Equine) should be administered to lactating women only if clearly indicated.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for North American Coral Snake Antivenin (Equine) and any potential adverse effects on the breastfed child from North American Coral Snake Antivenin (Equine) or from the underlying maternal condition.
8.4Pediatric Use Controlled clinical studies of safety and effectiveness in pediatric patients have not been conducted. Potential cases of Coral Snake envenomation and subsequent treatment with North American Coral Snake Antivenin (Equine) have been reported in pediatric patients; 2 adverse reactions included anaphylaxis (wheezing) requiring treatment with epinephrine, vomiting, and abdominal pain.
8.5Geriatric Use Specific studies in elderly patients have not been conducted.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available human data that establish developmental toxicity related to the use of North American Coral Snake Antivenin (Equine). There are no available animal data informing the North American Coral Snake Antivenin (Equine)-associated risk. North American Coral Snake Antivenin (Equine) should be given to a pregnant woman only if clearly required.
In the US general population, the background risk of major birth defects is 2–4% and of miscarriage is 15–20% in clinically recognized pregnancies.
🧒 Pediatric Use ▾
8.4Pediatric Use Controlled clinical studies of safety and effectiveness in pediatric patients have not been conducted. Potential cases of Coral Snake envenomation and subsequent treatment with North American Coral Snake Antivenin (Equine) have been reported in pediatric patients; 2 adverse reactions included anaphylaxis (wheezing) requiring treatment with epinephrine, vomiting, and abdominal pain.
🧓 Geriatric Use ▾
8.5Geriatric Use Specific studies in elderly patients have not been conducted.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action North American Coral Snake Antivenin (Equine) specifically binds to and neutralizes coral snake venom.
12.2Pharmacodynamics North American Coral Snake Antivenin (Equine) is standardized for potency in mice in terms of its LD 50 neutralizing capacity per milliliter as determined by intravenous injection of a graded series of mixtures of North American Coral Snake Antivenin (Equine) with M. f. fulvius venom. Based on this assay system, the reconstituted contents of each vial (10 mL) will neutralize approximately 250 mouse LD 50 or approximately 2 mg of M.f. fulvius venom. The results of cross-neutralization tests indicate that North American Coral Snake Antivenin (Equine) will neutralize the venom of M. fulvius tenere (Texas coral snake) but will not neutralize the venom of Micruroides euryxanthus (Arizona or Sonoran coral snake).
🧬 Mechanism of Action ▾
12.1Mechanism of Action North American Coral Snake Antivenin (Equine) specifically binds to and neutralizes coral snake venom.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING North American Coral Snake Antivenin (Equine) is supplied as a sterile lyophilized powder in single use vial (NDC 0008-0423-01) in a carton (NDC 0008-0423-03). Store vials between 2 and 8°C (36 and 46° F). Do not freeze. Use the reconstituted and diluted product within 4 hours.
📦 Storage and Handling ▾
Store vials between 2 and 8°C (36 and 46° F). Do not freeze. Use the reconstituted and diluted product within 4 hours.
📋 Description ▾
11 DESCRIPTION North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized with eastern coral snake ( Micrurus fulvius fulvius ) venom. Prior to lyophilization, the product contains 0.25% phenol.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to contact the physician or emergency department immediately if they experience any signs and symptoms of delayed allergic reactions or serum sickness up to 14 days following hospital discharge. Symptoms include rash, pruritus, joint pain, arthralgia, fever, lymphadenopathy, and malaise.