HAVRIX

Product NDC
50090-1502
11-digit product format
500901502
Labeler code
50090
Product ID
50090-1502_23d4b1bc-00aa-4756-9bb0-74f36cbc9f6d
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
2007-04-13
Substance
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
1440 [iU]/mL
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)1440 [iU]/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1502-0HAVRIX10 in 1 CARTONINJECTION, SUSPENSION1023
50090-1502-9HAVRIX1 mL in 1 SYRINGEINJECTION, SUSPENSION123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1502-0ML - Milliliter50090-15024ac7c8df-718b-4dd3-b076-f68a5a3424b512018-10-11
50090-1502-9ML - Milliliter50090-150293cb16c5-7423-435b-afb9-43d5841118e312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1502HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]23Current NDC, Legacy NDC, 2 package rows20231210_618a7f1b-7162-4d16-9076-51b8aab4c8d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
798479HAVRIX adult vaccine 1440 UNT in 1 ML Prefilled SyringePSN618a7f1b-7162-4d16-9076-51b8aab4c8d223
798477hepatitis A vaccine adult (HepA) 1440 UNT in 1 ML Prefilled SyringePSN618a7f1b-7162-4d16-9076-51b8aab4c8d223
7984791 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled Syringe [Havrix]SBD618a7f1b-7162-4d16-9076-51b8aab4c8d223
7984771 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled SyringeSCD618a7f1b-7162-4d16-9076-51b8aab4c8d223
798479Havrix, Hepatitis A Vaccine (Inactivated), (Adult Dose) 1 ML Prefilled SyringeSY618a7f1b-7162-4d16-9076-51b8aab4c8d223
798477hepatitis A vaccine (inactivated) strain HM175 1440 UNT per 1 ML Prefilled SyringeSY618a7f1b-7162-4d16-9076-51b8aab4c8d223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1502-05009015020010 SYRINGE in 1 CARTON (50090-1502-0) / 1 mL in 1 SYRINGE (50090-1502-9) 10 syringe2007-04-130000-00-00NoNoCurrent
50090-1502-9500901502091 mL in 1 SYRINGE1 mlHistorical