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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Y605XBM2GL |
| Rxcui | 1858981 |
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 |
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 |