FDA.reportPublic FDA data

Typhim Vi

Product NDC
49281-790
Requested package NDC
49281-790-51
11-digit product format
492810790
Labeler code
49281
Product ID
49281-790_225f8ffd-364f-441c-b0a3-9c5f701bbcf5
Type
VACCINE
Nonproprietary name
SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Sanofi Vaccines US Inc.
Application
BLA103936
Marketing category
BLA
Marketing start
1994-11-28
Substance
SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN
Active strength
25 ug/.5mL
Pharmacologic classes
Actively Acquired Immunity [PE], Inactivated Salmonella Typhi Vaccine [EPC], Polysaccharides, Bacterial [CS], Vaccines, Inactivated [CS], Vaccines, Typhoid [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Typhim Vi
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN25 ug/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49281-790-202025-08-13Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-202025-08-13Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-202025-08-13Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-512025-08-13Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-512025-08-13Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-512025-08-13Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-202025-07-29Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-202025-07-29Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-202025-07-29Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-512025-07-29Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-512025-07-29Typhoid Vi Polysaccharide Vaccine Typhim Vi ®
49281-790-512025-07-29Typhoid Vi Polysaccharide Vaccine Typhim Vi ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-790-20Typhim Vi1 in 1 PACKAGEINJECTION, SOLUTION112
49281-790-38Typhim Vi10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1012
49281-790-51Typhim Vi1 in 1 PACKAGEINJECTION, SOLUTION112
49281-790-88Typhim Vi0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-790-20ML - Milliliter49281-79004a4a342-d773-4ec9-85a6-f05d8f3180c212013-02-13
49281-790-38ML - Milliliter49281-7905848c92f-54bb-4c12-a9d1-27d09e29ed4412015-10-02
49281-790-51ML - Milliliter49281-790cc4d733e-9209-4bde-b13f-062591cdf03712013-02-13
49281-790-88ML - Milliliter49281-7904406adc6-8dc1-4a92-9517-a488fd13a2b312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGENACTIVE INGREDIENT7194H8W3KTTYPHIM VI (SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN) INJECTION, SOLUTION [SANOFI PASTEUR INC.]4
SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGENACTIVE MOIETY7194H8W3KTTYPHIM VI (SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN) INJECTION, SOLUTION [SANOFI PASTEUR INC.]4
PHENOLINACTIVE INGREDIENT339NCG44TVTYPHIM VI (SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN) INJECTION, SOLUTION [SANOFI PASTEUR INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTYPHIM VI (SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN) INJECTION, SOLUTION [SANOFI PASTEUR INC.]4
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TTYPHIM VI (SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN) INJECTION, SOLUTION [SANOFI PASTEUR INC.]4
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK665956TYPHIM VI (SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN) INJECTION, SOLUTION [SANOFI PASTEUR INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RTYPHIM VI (SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN) INJECTION, SOLUTION [SANOFI PASTEUR INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-790TYPHIM VI (SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN) INJECTION, SOLUTION [SANOFI PASTEUR INC.]10Current NDC, Legacy NDC, 4 package rows20230111_ad1fbe7f-2995-45dd-92f3-7baccaab85d9.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103936Typhim ViTyphoid Vi Polysaccharide Vaccine351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486496Typhim Vi 0.5 ML Prefilled SyringePSN5f674a82-00fb-41f8-99a5-df898577132419
807225Typhim Vi Injectable SolutionPSN21b75f1d-1cda-49e5-8176-cc23827824f319
807239typhoid Vi polysaccharide vaccine (generic for Typhim Vi) 0.5 ML Prefilled SyringePSN5f674a82-00fb-41f8-99a5-df898577132419
807222typhoid Vi polysaccharide vaccine (generic for Typhim Vi) Injectable SolutionPSN21b75f1d-1cda-49e5-8176-cc23827824f319
14864960.5 ML typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 0.05 MG/ML Prefilled Syringe [Typhim VI]SBD5f674a82-00fb-41f8-99a5-df898577132419
807225typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 0.05 MG/ML Injectable Solution [Typhim VI]SBD21b75f1d-1cda-49e5-8176-cc23827824f319
8072390.5 ML typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 0.05 MG/ML Prefilled SyringeSCD5f674a82-00fb-41f8-99a5-df898577132419
807222typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 0.05 MG/ML Injectable SolutionSCD21b75f1d-1cda-49e5-8176-cc23827824f319
14864960.5 ML Typhim VI 0.05 MG/ML Prefilled SyringeSY5f674a82-00fb-41f8-99a5-df898577132419
1486496Typhim VI 25 MCG per 0.5 ML Prefilled SyringeSY5f674a82-00fb-41f8-99a5-df898577132419
807225Typhim Vi, Typhoid Vi Polysaccharide Vaccine Injectable SolutionSY21b75f1d-1cda-49e5-8176-cc23827824f319
807239typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 0.025 MG per 0.5 ML Prefilled SyringeSY5f674a82-00fb-41f8-99a5-df898577132419
807222typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 25 MCG per 0.5 ML Injectable SolutionSY21b75f1d-1cda-49e5-8176-cc23827824f319
807239typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 25 MCG per 0.5 ML Prefilled SyringeSY5f674a82-00fb-41f8-99a5-df898577132419
1486496Typhim Vi 0.5 ML Prefilled SyringePSNad1fbe7f-2995-45dd-92f3-7baccaab85d912
807225Typhim Vi Injectable SolutionPSNad1fbe7f-2995-45dd-92f3-7baccaab85d912
807239typhoid Vi polysaccharide vaccine (generic for Typhim Vi) 0.5 ML Prefilled SyringePSNad1fbe7f-2995-45dd-92f3-7baccaab85d912
807222typhoid Vi polysaccharide vaccine (generic for Typhim Vi) Injectable SolutionPSNad1fbe7f-2995-45dd-92f3-7baccaab85d912
14864960.5 ML typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 0.05 MG/ML Prefilled Syringe [Typhim VI]SBDad1fbe7f-2995-45dd-92f3-7baccaab85d912
807225typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 0.05 MG/ML Injectable Solution [Typhim VI]SBDad1fbe7f-2995-45dd-92f3-7baccaab85d912
8072390.5 ML typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 0.05 MG/ML Prefilled SyringeSCDad1fbe7f-2995-45dd-92f3-7baccaab85d912
807222typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 0.05 MG/ML Injectable SolutionSCDad1fbe7f-2995-45dd-92f3-7baccaab85d912
14864960.5 ML Typhim VI 0.05 MG/ML Prefilled SyringeSYad1fbe7f-2995-45dd-92f3-7baccaab85d912
1486496Typhim VI 25 MCG per 0.5 ML Prefilled SyringeSYad1fbe7f-2995-45dd-92f3-7baccaab85d912
807225Typhim Vi, Typhoid Vi Polysaccharide Vaccine Injectable SolutionSYad1fbe7f-2995-45dd-92f3-7baccaab85d912
807239typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 0.025 MG per 0.5 ML Prefilled SyringeSYad1fbe7f-2995-45dd-92f3-7baccaab85d912
807222typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 25 MCG per 0.5 ML Injectable SolutionSYad1fbe7f-2995-45dd-92f3-7baccaab85d912
807239typhoid Vi polysaccharide vaccine, S typhi Ty2 strain 25 MCG per 0.5 ML Prefilled SyringeSYad1fbe7f-2995-45dd-92f3-7baccaab85d912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-790-51492810790511 SYRINGE in 1 PACKAGE (49281-790-51) / .5 mL in 1 SYRINGE (49281-790-88) 1 syringe1994-11-280000-00-00NoNoCurrent