FDA.reportPublic FDA data

VAQTA

Product NDC
0006-4095
11-digit product format
000064095
Labeler code
0006
Product ID
0006-4095_287d69ba-8eec-4e38-b787-ce9ddfb0e172
Type
VACCINE
Nonproprietary name
hepatitis A vaccine, inactivated
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Merck Sharp & Dohme LLC
Application
BLA103606
Marketing category
BLA
Marketing start
1996-03-29
Substance
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
25 [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
VAQTA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)25 [iU]/.5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4095-01VAQTA0.5 mL in 1 SYRINGEINJECTION, SUSPENSION0.528
0006-4095-02VAQTA10 in 1 CARTONINJECTION, SUSPENSION1028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4095-01ML - Milliliter0006-409501915dcf-5310-4a65-ac09-1e910bbf1b3312014-08-01
0006-4095-02ML - Milliliter0006-4095bb2008f4-f55f-49d8-b87d-93d01104210e12014-08-01
0006-4095-09ML - Milliliter0006-40953e31002e-d76d-479e-b73e-c63cc87a98ef12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTQ04Q922K9QVAQTA (HEPATITIS A VACCINE, INACTIVATED) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]15
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYQ04Q922K9QVAQTA (HEPATITIS A VACCINE, INACTIVATED) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]15
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOVAQTA (HEPATITIS A VACCINE, INACTIVATED) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XVAQTA (HEPATITIS A VACCINE, INACTIVATED) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]15
WATERINACTIVE INGREDIENT059QF0KO0RVAQTA (HEPATITIS A VACCINE, INACTIVATED) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4095VAQTA (HEPATITIS A VACCINE, INACTIVATED) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]27Current NDC, Legacy NDC, 2 package rows20241116_89191ae9-7f2b-4206-8397-bf7fce3436ac.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103606VaqtaHepatitis A Vaccine Inactivated351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658100hepatitis A virus strain CR 326F antigen, inactivated adult (HepA) 50 UNT in 1 mL InjectionPSN89191ae9-7f2b-4206-8397-bf7fce3436ac28
727782hepatitis A virus strain CR 326F antigen, inactivated adult (HepA) 50 UNT in 1 mL Prefilled SyringePSN89191ae9-7f2b-4206-8397-bf7fce3436ac28
1658105hepatitis A virus strain CR 326F antigen, inactivated pediatric/adolescent (HepA) 25 UNT in 0.5 mL InjectionPSN89191ae9-7f2b-4206-8397-bf7fce3436ac28
836635hepatitis A virus strain CR 326F antigen, inactivated pediatric/adolescent (HepA) 25 UNT in 0.5 mL Prefilled SyringePSN89191ae9-7f2b-4206-8397-bf7fce3436ac28
1658102VAQTA adult vaccine 1 ML InjectionPSN89191ae9-7f2b-4206-8397-bf7fce3436ac28
836634VAQTA adult vaccine 1 ML Prefilled SyringePSN89191ae9-7f2b-4206-8397-bf7fce3436ac28
1658106VAQTA pediatric/adolescent vaccine 0.5 ML InjectionPSN89191ae9-7f2b-4206-8397-bf7fce3436ac28
836636VAQTA vaccine pediatric/adolescent 0.5 ML Prefilled SyringePSN89191ae9-7f2b-4206-8397-bf7fce3436ac28
16581060.5 ML hepatitis A virus strain CR 326F antigen, inactivated 50 UNT/ML Injection [Vaqta]SBD89191ae9-7f2b-4206-8397-bf7fce3436ac28
8366360.5 ML hepatitis A virus strain CR 326F antigen, inactivated 50 UNT/ML Prefilled Syringe [Vaqta]SBD89191ae9-7f2b-4206-8397-bf7fce3436ac28
16581021 ML hepatitis A virus strain CR 326F antigen, inactivated 50 UNT/ML Injection [Vaqta]SBD89191ae9-7f2b-4206-8397-bf7fce3436ac28
8366341 ML hepatitis A virus strain CR 326F antigen, inactivated 50 UNT/ML Prefilled Syringe [Vaqta]SBD89191ae9-7f2b-4206-8397-bf7fce3436ac28
16581050.5 ML hepatitis A virus strain CR 326F antigen, inactivated 50 UNT/ML InjectionSCD89191ae9-7f2b-4206-8397-bf7fce3436ac28
8366350.5 ML hepatitis A virus strain CR 326F antigen, inactivated 50 UNT/ML Prefilled SyringeSCD89191ae9-7f2b-4206-8397-bf7fce3436ac28
16581001 ML hepatitis A virus strain CR 326F antigen, inactivated 50 UNT/ML InjectionSCD89191ae9-7f2b-4206-8397-bf7fce3436ac28
7277821 ML hepatitis A virus strain CR 326F antigen, inactivated 50 UNT/ML Prefilled SyringeSCD89191ae9-7f2b-4206-8397-bf7fce3436ac28
16581060.5 ML Vaqta 50 UNT/ML InjectionSY89191ae9-7f2b-4206-8397-bf7fce3436ac28
8366360.5 ML Vaqta 50 UNT/ML Prefilled SyringeSY89191ae9-7f2b-4206-8397-bf7fce3436ac28
16581021 ML Vaqta 50 UNT/ML InjectionSY89191ae9-7f2b-4206-8397-bf7fce3436ac28
8366341 ML Vaqta 50 UNT/ML Prefilled SyringeSY89191ae9-7f2b-4206-8397-bf7fce3436ac28
1658105hepatitis A virus strain CR 326F antigen, inactivated 25 UNT per 0.5 ML InjectionSY89191ae9-7f2b-4206-8397-bf7fce3436ac28
836635hepatitis A virus strain CR 326F antigen, inactivated 25 UNT per 0.5 ML Prefilled SyringeSY89191ae9-7f2b-4206-8397-bf7fce3436ac28
727782hepatitis A virus strain CR 326F antigen, inactivated 50 UNT per 1 ML Prefilled SyringeSY89191ae9-7f2b-4206-8397-bf7fce3436ac28
1658106Vaqta 25 UNT per 0.5 ML InjectionSY89191ae9-7f2b-4206-8397-bf7fce3436ac28
836636Vaqta 25 UNT per 0.5 ML Prefilled SyringeSY89191ae9-7f2b-4206-8397-bf7fce3436ac28
1658102Vaqta 50 UNT per 1 ML InjectionSY89191ae9-7f2b-4206-8397-bf7fce3436ac28
836634Vaqta 50 UNT per 1 ML Prefilled SyringeSY89191ae9-7f2b-4206-8397-bf7fce3436ac28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-4095-01000064095010.5 mL in 1 SYRINGE0.5 mlHistorical
0006-4095-020000640950210 SYRINGE in 1 CARTON (0006-4095-02) / .5 mL in 1 SYRINGE (0006-4095-01) 10 syringe1996-03-290000-00-00NoNoCurrent