Vivotif

Product NDC
69401-000
11-digit product format
694010000
Labeler code
69401
Product ID
69401-000_4e9fb5c9-453a-4e24-ad62-4ea03ac734e0
Type
VACCINE
Nonproprietary name
Salmonella typhi Ty21a
Dosage form
CAPSULE, COATED
Route
ORAL
Labeler
Emergent Travel Health Inc.
Application
BLA103123
Marketing category
BLA
Marketing start
1992-03-16
Marketing end
0000-00-00
Substance
SALMONELLA TYPHI TY21A LIVE ANTIGEN
Active strength
2147483647 [CFU]/1
Pharmacologic classes
Live Attenuated Salmonella Typhi Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Typhoid [CS],Vaccines, Attenuated [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct69401-000DDiscontinued by firm2026-08-17
excluded packagepackage69401-00069401-000-02DDiscontinued by firm2026-08-17

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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69401-000-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69401-000-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69401-000-02UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69401-000-02UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69401-000-02UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69401-000-022025-02-18C16284748780-12cef2736-aa2a-d83d-e063-dadaa90ab31fTyphoid Vaccine Live Oral Ty21a Vivotif ®
69401-000-022025-01-30C16284748780-12cef2736-aa2a-d83d-e063-dadaa90ab31fTyphoid Vaccine Live Oral Ty21a Vivotif ®

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69401-000-01EA - Each69401-0009033dc2f-e77c-4467-9e51-db757a59b12b12016-01-13
69401-000-02EA - Each69401-000bc9ef7ad-fd1a-45e3-9951-0f614dd0019912017-06-15

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69401-000VIVOTIF (SALMONELLA TYPHI TY21A) CAPSULE, COATED [EMERGENT TRAVEL HEALTH INC.]7Legacy NDC20250221_168a670b-0cbb-067c-e054-00144ff88e88.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103123VivotifTyphoid Vaccine Live Oral Ty21a351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762598typhoid vaccine live Ty21a 2,000,000,000 UNT Delayed Release Oral CapsulePSN194fde77-eaf8-4e4c-84ef-35d67b5eec1117
762602Vivotif 2,000,000,000 UNT Delayed Release Oral CapsulePSN194fde77-eaf8-4e4c-84ef-35d67b5eec1117
762602Salmonella typhi Ty21a live antigen 2000000000 UNT Delayed Release Oral Capsule [Vivotif]SBD194fde77-eaf8-4e4c-84ef-35d67b5eec1117
762598Salmonella typhi Ty21a live antigen 2000000000 UNT Delayed Release Oral CapsuleSCD194fde77-eaf8-4e4c-84ef-35d67b5eec1117
762598typhoid vaccine live Ty21a 2,000,000,000 UNT Delayed Release Oral CapsuleSY194fde77-eaf8-4e4c-84ef-35d67b5eec1117
762602Vivotif 2,000,000,000 UNT Delayed Release Oral CapsuleSY194fde77-eaf8-4e4c-84ef-35d67b5eec1117
762602Vivotif Berna 2,000,000,000 UNT Delayed Release Oral CapsuleSY194fde77-eaf8-4e4c-84ef-35d67b5eec1117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69401-000-02694010000021 BLISTER PACK in 1 CARTON (69401-000-02) > 4 CAPSULE, COATED in 1 BLISTER PACK (69401-000-01) 1 blister pack1992-03-160000-00-00NoNoCurrent