Home NDC 0008-0423 North American Coral Snake Antivenin (Equine)
Product NDC 0008-0423
11-digit product format 000080423
Labeler code 0008
Product ID 0008-0423_7a16fb9b-c963-48d9-90f9-b428857ab5de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Coral Snake (Micrurus Fulvius) Immune Globulin Antivenin (Equine)
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application BLA101099
Marketing category BLA
Marketing start 2016-10-12
Substance CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)
Active strength 250 [arb'U]/10mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base North American Coral Snake Antivenin (Equine)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) 250 [arb'U]/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y605XBM2GL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1858981 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0008-0423-01 North American Coral Snake Antivenin (Equine) 10 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 10 7 0008-0423-03 North American Coral Snake Antivenin (Equine) 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NORTH AMERICAN CORAL SNAKE ANTIVENIN (MICRURUS FULVIUS) (EQUINE) ACTIVE INGREDIENT Y605XBM2GL ANTIVENIN (MICRURUS FULVIUS) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS COMPANY] 1 NORTH AMERICAN CORAL SNAKE ANTIVENIN (MICRURUS FULVIUS) (EQUINE) ACTIVE MOIETY Y605XBM2GL ANTIVENIN (MICRURUS FULVIUS) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS COMPANY] 1 PHENOL INACTIVE INGREDIENT 339NCG44TV ANTIVENIN (MICRURUS FULVIUS) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS COMPANY] 1 THIMEROSAL INACTIVE INGREDIENT 2225PI3MOV ANTIVENIN (MICRURUS FULVIUS) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS COMPANY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0008-0423 NORTH AMERICAN CORAL SNAKE ANTIVENIN (EQUINE) (CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] 7 Current NDC, Legacy NDC, 2 package rows 20221123_6d0f94b4-82ca-37c7-edb0-4f0702cf6c8d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 101099 Antivenin (Micrurus fulvius) 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0008-0423-01 00008042301 10 mL in 1 VIAL 10 ml Historical 0008-0423-03 00008042303 1 VIAL in 1 CARTON (0008-0423-03) / 10 mL in 1 VIAL (0008-0423-01) 1 vial 2016-10-12 0000-00-00 No No Current