HAVRIX

Product NDC
50090-3781
11-digit product format
500903781
Labeler code
50090
Product ID
50090-3781_e0a78abf-4f24-4c13-ac00-6c193441275d
Type
VACCINE
Nonproprietary name
Hepatitis A Vaccine
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
BLA103475
Marketing category
BLA
Marketing start
2007-02-16
Substance
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
720 [iU]/.5mL
Pharmacologic classes
Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HAVRIX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)720 [iU]/.5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3781-0HAVRIX10 in 1 CARTONINJECTION, SUSPENSION1013
50090-3781-1HAVRIX.5 mL in 1 SYRINGEINJECTION, SUSPENSION.513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3781-0ML - Milliliter50090-378193c258d4-7610-404b-80be-a2cb2e484c2a12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3781HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]13Current NDC, 2 package rows20240627_7df68090-7e98-4b01-9c29-0b941a1c307d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
798482HAVRIX pediatric/adolescent vaccine 720 UNT in 0.5 ML Prefilled SyringePSN7df68090-7e98-4b01-9c29-0b941a1c307d13
798481hepatitis A vaccine pediatric/adolescent (HepA) 720 UNT in 0.5 ML Prefilled SyringePSN7df68090-7e98-4b01-9c29-0b941a1c307d13
7984820.5 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled Syringe [Havrix]SBD7df68090-7e98-4b01-9c29-0b941a1c307d13
7984810.5 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled SyringeSCD7df68090-7e98-4b01-9c29-0b941a1c307d13
798482Havrix 720 UNT per 0.5 ML Prefilled Syringe, 0.5 MLSY7df68090-7e98-4b01-9c29-0b941a1c307d13
798482Havrix, Hepatitis A Vaccine (Inactivated), (Pediatric Dose) 0.5 ML Prefilled SyringeSY7df68090-7e98-4b01-9c29-0b941a1c307d13
798481hepatitis A vaccine (inactivated) strain HM175 720 UNT per 0.5 ML Prefilled SyringeSY7df68090-7e98-4b01-9c29-0b941a1c307d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-3781-05009037810010 SYRINGE in 1 CARTON (50090-3781-0) / .5 mL in 1 SYRINGE (50090-3781-1) 10 syringe2007-02-16NoNoCurrent
50090-3781-150090378101.5 mL in 1 SYRINGEHistorical