FDA.reportPublic FDA data

Vaxchora

Product NDC
70460-004
Requested package NDC
70460-004-01
11-digit product format
704600004
Labeler code
70460
Product ID
70460-004_1fd8c474-67a7-4064-8cb7-45b96aaf5a41
Type
VACCINE
Nonproprietary name
Cholera Vaccine, Live, Oral
Dosage form
KIT
Labeler
Emergent Travel Health Inc.
Application
BLA125597
Marketing category
BLA
Marketing start
2020-02-13
Marketing end
0000-00-00
Active strength
0
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70460-00470460-004-01DDiscontinued by firm2026-10-05

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 packagepackage70460-00470460-004-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70460-00470460-004-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70460-004-01ML - Milliliter70460-00406a31a71-650d-4247-911f-d52a7410f59612019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70460-004VAXCHORA (CHOLERA VACCINE, LIVE, ORAL) KIT [EMERGENT TRAVEL HEALTH INC.]8Legacy NDC20240113_7baa7ebb-cb08-4799-80d4-66c16966d223.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125597VaxchoraCholera Vaccine, Live, Oral351(a)Rx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70460-004-01704600004011 KIT in 1 CARTON (70460-004-01) * 1 POWDER, FOR SUSPENSION in 1 PACKET (70460-002-02) * 1 POWDER, FOR SUSPENSION in 1 PACKET (70460-003-02) 1 kit2020-02-130000-00-00NoNoCurrent