FDA.reportPublic FDA data

Vivotif-B

Product NDC
21695-526
11-digit product format
216950526
Labeler code
21695
Product ID
21695-526_31fe1e75-da67-4e6d-a529-8b82905dad45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vivotif-B
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
BLA103123
Marketing category
BLA
Marketing start
1989-12-15
Marketing end
0000-00-00
Substance
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI
Active strength
2 [CFU]/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-526-042019-09-24C16284748780-1934fe258-4a8b-48b1-e053-8cdaa90a720aVivotif-B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-526-04Vivotif-B4 in 1 BLISTER PACKCAPSULE41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-526-04EA - Each21695-52675ddc99d-ae46-4c4e-97cb-696fbc6ae11112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHIACTIVE INGREDIENT760T5R8B3OVIVOTIF-B CAPSULE [REBEL DISTRIBUTORS CORP]1
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHIACTIVE MOIETY760T5R8B3OVIVOTIF-B CAPSULE [REBEL DISTRIBUTORS CORP]1
AMINO ACIDSINACTIVE INGREDIENT0O72R8RF8AVIVOTIF-B CAPSULE [REBEL DISTRIBUTORS CORP]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RVIVOTIF-B CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GVIVOTIF-B CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIVOTIF-B CAPSULE [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554VIVOTIF-B CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-526VIVOTIF-B CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110323_31fe1e75-da67-4e6d-a529-8b82905dad45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762598typhoid vaccine live Ty21a 2,000,000,000 UNT Delayed Release Oral CapsulePSN31fe1e75-da67-4e6d-a529-8b82905dad451
762598Salmonella typhi Ty21a live antigen 2000000000 UNT Delayed Release Oral CapsuleSCD31fe1e75-da67-4e6d-a529-8b82905dad451
762598typhoid vaccine live Ty21a 2,000,000,000 UNT Delayed Release Oral CapsuleSY31fe1e75-da67-4e6d-a529-8b82905dad451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-526-04216950526044 in 1 BLISTER PACKHistorical