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Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

North American Coral Snake Antivenin (Equine) Coral Snake (Micrurus Fulvius) Immune Globulin 250 [arb'U]/10mL Injection, Powder, For Solution — NDC 0008-0423-03 (Billing 00008-0423-03)

by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. · 1 VIAL in 1 CARTON / 10 mL in 1 VIAL

This is a package of North American Coral Snake Antivenin (Equine) Coral Snake (Micrurus Fulvius) Immune Globulin 250 [arb'U]/10mL Injection, Powder, For Solution from Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., marketed since Oct 2016 and currently FDA-listed. It is this product's only package size.

NDC 00008-0423-03

🏷️ FDA NDC (as labeled) 0008-0423-03 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 →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

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 0008-0423-03 alone.

Record: FDA NDC Directory package listing · Human prescription drug
Code segments: 0008 labeler · 0423 product · 03 package
Package marketed since: Oct 12, 2016
Sample package: No — commercial package
Listing certified through: Dec 31, 2026
Barcode (UPC-A, from the NDC): 3 0008042303 5
FDA record last changed: Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0008-0423-03

Product NDC 0008-0423

11-digit billing NDC 00008042303

NCPDP billing unit EA — each (per item)

RxCUI 1858981

UNII Y605XBM2GL

Application # BLA101099

SPL Set ID 6d0f94b4-82ca-37c7-edb0-4f0702cf6c8d

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2016-10-12

Route INTRAVENOUS

Dosage form INJECTION, POWDER, FOR SOLUTION

Substance CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)

Biologic (Purple Book) 351(a)

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

GPI-14 19200040002100

GPI class Antivenin Micrurus Fulvius

GCN Seq No 009694

GCN 44000

HICL code 004223

Ingredient (HICL) Antivenin,Micrurus Fulvius

HIC1 code W

Therapeutic class — broad (HIC1) Anti-Infecting Agents

HIC2 code W7

Therapeutic class — intermediate (HIC2) Biologicals

HIC3 code W7S

Therapeutic class — specific (HIC3) Antivenins

AHFS code 80:04.00.00

AHFS class Antitoxins And Immune Globulins

FDB label name ANTIVENIN MICRURUS FULVIUS

FDB brand name Antivenin Micrurus Fulvius

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 009694
GCN: 44000
GPI-14 (Medi-Span): 19200040002100
HICL (First Databank): 004223
AHFS class code: 80:04.00.00
RxCUI (RxNorm): 1858981

Why two NDCs? The FDA registers this code as 0008-0423-03 — 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 → 00008-0423-03. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

FDA openFDA NDC Directory · synced Oct 8, 2026
FDA label on DailyMed · label index refreshed Oct 6, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 8, 2026

Clinical

Label name ANTIVENIN MICRURUS FULVIUS Ingredient Antivenin,Micrurus Fulvius

Patient education

📘 MedlinePlus patient leaflet ↗

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 6, 2026

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.

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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
00008-0423-03 You're viewing this Main listing	1 VIAL in 1 CARTON / 10 mL in 1 VIAL	2016-10-12	—	Active

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	—

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.

FDA openFDA NDC Directory · synced Oct 8, 2026
FDA Purple Book · refreshed Oct 5, 2026
CMS NADAC weekly file

Availability & biosimilar status

🏛️

1967

First FDA approval

Aug 1967

📍

2026

Currently FDA-listed

59 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.

FDA Purple Book · refreshed Oct 5, 2026

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
UNII 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.

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.

FDA label on DailyMed · label index refreshed Oct 6, 2026
FDA openFDA NDC Directory · synced Oct 8, 2026

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

LabelerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

FDA applicationBLA101099 (BLA)

Labeler code00008

First marketedOct 2016

Product typeHuman Prescription Drug

Portfolio31 products on file

More NDCs from Wyeth Pharmaceuticals LLC, a subsidiary of Pfize... labeler code 00008

🔎 All NDCs from Wyeth Pharmaceuticals LLC, a subsidiary...

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.

FDA openFDA NDC Directory · synced Oct 8, 2026
Drugs@FDA

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacodynamics 🔬 Clinical Studies 📚 References 📄 Package Label / Principal Display Panel

🎯 Indications and Usage 62 words ▾

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 ~3 min read ▾

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 68 words ▾

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 103 words ▾

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 198 words ▾

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 89 words ▾

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 ~1 min read ▾

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 80 words ▾

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 53 words ▾

🧓 Geriatric Use 12 words ▾

8.5Geriatric Use Specific studies in elderly patients have not been conducted.

🧬 Clinical Pharmacology 134 words ▾

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 18 words ▾

12.1Mechanism of Action North American Coral Snake Antivenin (Equine) specifically binds to and neutralizes coral snake venom.

📦 How Supplied / Storage and Handling 51 words ▾

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 22 words ▾

Store vials between 2 and 8°C (36 and 46° F). Do not freeze. Use the reconstituted and diluted product within 4 hours.

📋 Description 49 words ▾

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 46 words ▾

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.

🧬 Pharmacodynamics 113 words ▾

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES There have been no well-controlled clinical studies of the use of North American Coral Snake Antivenin (Equine) in patients experiencing envenomation by the Eastern Coral Snake, however a retrospective analysis 3 has been published of 387 coral snake exposures treated in a healthcare facility in Florida between 1998 and 2010, including 252 patients who were treated with North American Coral Snake Antivenin (Equine). Patients were managed according to different treatment strategies: (a) asymptomatic at ED arrival and treated empirically (n=134); (b) asymptomatic at ED arrival, but treatment withheld until symptoms appeared (n=106; 6 of the 106 received North American Coral Snake Antivenin (Equine) at some point; the remainder were never treated); (c) symptomatic at ED arrival and treated with North American Coral Snake Antivenin (Equine) (n=112); and (d) symptomatic at ED arrival but not treated with North American Coral Snake Antivenin (Equine) (n=35).

The average number of vials administered to treated patients was 3.75 (range 1 – 20 vials); the 17 patients who received repeat treatment were administered 8.3 vials, on average. There was no reported usage of foreign antivenom or acetylcholinesterase inhibitors in this case series. The 387 patients were assessed for clinical outcomes, as shown in Table 1.

Outcomes codes range from full recovery with no residual effects ("No Effect") to less than full recovery with significant residual effects ("Major"). Empiric treatment of asymptomatic patients resulted in more 'moderate' and 'major' outcomes compared to withholding treatment until symptoms appeared (p<.001), however, the patients were not randomized and selection biases could have affected this result. Table 1 – Outcome by Treatment Strategy Treatment Strategy Empiric (N = 134) Withhold (N = 106) Symptomatic with AV (N = 112) Symptomatic without AV (N = 35) ADR, adverse drug reaction; AV, antivenom; Avg, average; LOS, length of stay; ICU, intensive care unit.

Primary outcome Endotracheal intubation (%) 3 (2.2) 1 (0.94) 7 (6.25) 0 (0) Secondary outcomes Days intubated Avg. (SD) 5.67 (2.89) 24 (N/A) 8 (6.22) 0 (0) ICU admission (%) p < 0.01 between empiric and withhold strategies. 97 (72.39) 49 (46.23) 90 (80.36) 9 (25.71) ICU LOS Avg.(SD) 1.5 (1.18) 1.73 (3.28) 2.25 (3.35) 1.3 (0.5) Total LOS Avg.(SD) 1.58 (1.56) 1.17 (2.94) 2.47 (3.68) 0.94 (0.85) Antivenom ADR (%) 26 (19.4) 0 (0) 20 (17.86) 0 (0) Outcome code % No Effect 4.76 29.29 0 0 Minor 71.43 56.57 34.23

63.64Moderate 20.63 13.13 54.05

36.36Major 3.17 1.01 11.71 0 Adverse reactions associated with North American Coral Snake Antivenin (Equine) administration were documented in 46 (18.25%) cases. The most common adverse reactions were hives, rash and/or welts (12%); itching (9%); shortness of breath (8%); hypotension (2%) and angioedema (1%). Antihistamines were administered to 46 patients, corticosteroids to 40, and epinephrine to 10 cases to treat these adverse reactions.

📚 References 73 words ▾

15 REFERENCES 1. Bowden, C and Krenzelok, E: Clinical applications of commonly used contemporary antidotes, a US perspective. Drug Safety 1997; 16(1):9-47.

2. Sasaki, J et al: Coral snake bites and envenomation in children, A case series. Ped Emerg Care 2014; 30(4):262-5.

3. Wood A, Schauben J, Thundiyil J, et al. Review of Eastern coral snake (Micrurus fulvius fulvius) exposures managed by the Florida Poison Information Center Network: 1998-2010.

Clin Toxicol 2013; 51(8):783-8.

📄 Package Label / Principal Display Panel 99 words ▾

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label NDC 0008-0423-01 North American Coral Snake Antivenin (Equine) 10 mL Lyophilized Powder for Solution for Intravenous Injection Rx only PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton NDC 0008-0423-03 Contains 1 of NDC 0008-0423-01 North American Coral Snake Antivenin (Equine) 10 mL Lyophilized Powder for Solution for Intravenous Injection This package contains one vial of lyophilized Antivenin (Micrurus fulvius) with 0.25% phenol as a preservative (before lyophilization). Sealed under partial vacuum. Pfizer Injectables Rx only PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

Glossary — plain-language definitions of medical terms used in this label:

case series: A report describing what happened to a small group of patients, with no comparison group.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

arthralgia: Joint pain.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diluent: The liquid used to dissolve or thin a medicine before it is given.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

edema: Swelling caused by extra fluid trapped in the body's tissues.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

lyophilized: Freeze-dried into a powder that is mixed with liquid before it is given.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

myalgia: Muscle pain or aching.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

pruritus: Itching of the skin.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

reconstitution: Mixing a powdered medicine with a liquid to prepare it for use, following the label's directions.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

serum sickness: A delayed reaction, usually one to two weeks after exposure, causing fever, rash, and joint pain as the body reacts to a foreign substance.

stridor: A harsh, high-pitched sound heard when breathing in, caused by narrowing of the upper airway.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

wheezing: A high-pitched whistling sound made while breathing, usually when the airways are narrowed.

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

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer 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.

← 00008-0100-01 · Wyeth 00008-0836-21 · Wyeth →

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.

North American Coral Snake Antivenin (Equine) Coral Snake (Micrurus Fulvius) Immune Globulin 250 [arb'U]/10mL Injection, Powder, For Solution — NDC 0008-0423-03 (Billing 00008-0423-03)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

Clinical

Patient education

Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Therapeutic equivalents

Availability & biosimilar status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from Wyeth Pharmaceuticals LLC, a subsidiary of Pfize... labeler code 00008

Full prescribing information FDA SPL

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

About this NDC listing & data coverage

Questions about this listing

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