FDA.reportPublic FDA data

Vaxchora

Product NDC
70460-001
Requested package NDC
70460-001-01
11-digit product format
704600001
Labeler code
70460
Product ID
70460-001_aa67e293-7e9e-4b1d-9637-17ce3a0161a4
Type
VACCINE
Nonproprietary name
Cholera Vaccine, Live, Oral
Dosage form
KIT
Labeler
Paxvax, Inc.
Application
BLA125597
Marketing category
BLA
Marketing start
2016-10-03
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70460-00170460-001-01DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70460-001-012021-08-16C16284748780-1c7ccaba7-1269-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use VAXCHORA safely and effectively. See full prescribing information for VAXCHORA. VAXCHORA ® (Cholera Vaccine, Live, Oral) Suspension for Oral Administration Initial U.S. Approval: 2016
70460-001-012021-07-23C16284748780-1c7ccaba7-1269-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use VAXCHORA safely and effectively. See full prescribing information for VAXCHORA. VAXCHORA ® (Cholera Vaccine, Live, Oral) Suspension for Oral Administration Initial U.S. Approval: 2016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70460-001-01ML - Milliliter70460-0013410d263-63df-48b1-a9ea-10062e0d14e212016-11-08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125597VaxchoraCholera Vaccine, Live, Oral351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70460-001-01704600001011 KIT in 1 CARTON (70460-001-01) * 1 POWDER, FOR SUSPENSION in 1 PACKET (70460-002-02) * 1 POWDER, FOR SUSPENSION in 1 PACKET (70460-003-02) 1 kit2016-10-030000-00-00NoNoCurrent