FDA.reportPublic FDA data

ERVEBO

Product NDC
0006-4293
11-digit product format
000064293
Labeler code
0006
Product ID
0006-4293_1683e411-3753-49a1-82da-de015167d504
Type
VACCINE
Nonproprietary name
ZAIRE EBOLAVIRUS (STRAIN KIKWIT-95) ENVELOPE GLYCOPROTEIN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Merck Sharp & Dohme LLC
Application
BLA125690
Marketing category
BLA
Marketing start
2019-12-19
Substance
ZAIRE EBOLAVIRUS (STRAIN KIKWIT-95) ENVELOPE GLYCOPROTEIN
Active strength
72000000 [PFU]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZAIRE EBOLAVIRUS (STRAIN KIKWIT-95) ENVELOPE GLYCOPROTEIN72000000 [PFU]/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4293-01ERVEBO1.0 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1.016
0006-4293-02ERVEBO10 in 1 CARTONINJECTION, SOLUTION1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4293-01ML - Milliliter0006-429339a7d07f-af9f-4741-991c-20968b78cfb912024-08-12
0006-4293-02ML - Milliliter0006-429384f75957-d756-4695-acc2-ad64fadf851912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4293ERVEBO (ZAIRE EBOLAVIRUS (STRAIN KIKWIT-95) ENVELOPE GLYCOPROTEIN) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC]16Current NDC, Legacy NDC, 2 package rows20250212_2b1db7a1-c3f2-42e5-8499-91724edbf65e.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125690ErveboEbola Zaire Vaccine, Live351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2624752ERVEBO 72,000,000 UNT in 1 ML InjectionPSN2b1db7a1-c3f2-42e5-8499-91724edbf65e16
2624746Zaire ebolavirus (strain Kikwit-95) envelope glycoprotein 72,000,000 UNT in 1 ML InjectionPSN2b1db7a1-c3f2-42e5-8499-91724edbf65e16
26247521 ML Zaire ebolavirus (strain Kikwit-95) envelope glycoprotein 72000000 UNT/ML Injection [Ervebo]SBD2b1db7a1-c3f2-42e5-8499-91724edbf65e16
26247461 ML Zaire ebolavirus (strain Kikwit-95) envelope glycoprotein 72000000 UNT/ML InjectionSCD2b1db7a1-c3f2-42e5-8499-91724edbf65e16
2624752Ervebo 72,000,000 UNT per 1 ML InjectionSY2b1db7a1-c3f2-42e5-8499-91724edbf65e16
2624746Zaire ebolavirus (strain Kikwit-95) envelope glycoprotein 72,000,000 UNT per 1 ML InjectionSY2b1db7a1-c3f2-42e5-8499-91724edbf65e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-4293-01000064293011.0 mL in 1 VIAL, SINGLE-DOSE1.0 mlHistorical
0006-4293-020000642930210 VIAL, SINGLE-DOSE in 1 CARTON (0006-4293-02) / 1 mL in 1 VIAL, SINGLE-DOSE (0006-4293-01) 2019-12-190000-00-00NoNoCurrent