FDA.reportPublic FDA data

VariZig

Product NDC
70257-126
11-digit product format
702570126
Labeler code
70257
Product ID
70257-126_272379b7-f0e7-4560-8d79-3fd0024c3010
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Varicella Zoster Immune Globulin (Human)
Dosage form
SOLUTION
Route
INTRAMUSCULAR
Labeler
Saol Therapeutics Inc.
Application
BLA125430
Marketing category
BLA
Marketing start
2019-03-01
Marketing end
0000-00-00
Substance
HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN
Active strength
125 [iU]/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70257-126DDiscontinued by firm2026-08-03
excluded packagepackage70257-12670257-126-51DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct70257-126DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70257-12670257-126-51DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70257-126-11ML - Milliliter70257-1260c577de0-e4c8-4165-a9a7-055cd4e3fff712019-06-19
70257-126-51ML - Milliliter70257-1268562a9e4-e132-4c6e-8d14-66cace91ddc512019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70257-126VARIZIG (HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN) SOLUTION [SAOL THERAPEUTICS]3Legacy NDC20230331_1cec80c5-a2b3-459f-959e-d6febfd2671c.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125430VarizigVaricella Zoster Immune Globulin (Human)351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70257-126-51702570126511 VIAL in 1 CARTON (70257-126-51) > 1.25 mL in 1 VIAL (70257-126-11) 1 vial2019-03-010000-00-00NoNoCurrent