FDA.reportPublic FDA data

Diluent for ACAM2000

Product NDC
71665-340
11-digit product format
716650340
Labeler code
71665
Product ID
71665-340_52ed1149-d6e1-49af-bae5-96b9d248009c
Type
VACCINE
Nonproprietary name
diluent for smallpox and mpox (vaccinia) vaccine, live
Dosage form
SOLUTION
Route
PERCUTANEOUS
Labeler
Emergent Product Development Gaithersburg Inc.
Application
BLA125158
Marketing category
BLA
Marketing start
2007-08-31
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diluent for ACAM2000
Listing expiration
2026-12-31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71665-340-01Diluent for ACAM20000.6 mL in 1 VIAL, GLASSSOLUTION0.62
71665-340-02Diluent for ACAM200050 in 1 CARTONSOLUTION502
71665-340-03Diluent for ACAM20008 in 1 CASESOLUTION82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71665-340ACAM2000 (SMALLPOX AND MPOX (VACCINIA) VACCINE, LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION DILUENT FOR ACAM2000 (DILUENT FOR SMALLPOX AND MPOX (VACCINIA) VACCINE, LIVE) SOLUTION [EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.]2Current NDC, 3 package rows20250328_f8b2634b-ccd7-4a42-8db3-26ba9e9627e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833086ACAM2000 smallpox (vaccinia) vaccine, live Injectable SolutionPSNf8b2634b-ccd7-4a42-8db3-26ba9e9627e62
833082smallpox (vaccinia) vaccine, live Injectable SolutionPSNf8b2634b-ccd7-4a42-8db3-26ba9e9627e62
833086smallpox vaccine live, New York City Board of Health vaccinia strain 500000000 UNT/ML Injectable Solution [ACAM2000]SBDf8b2634b-ccd7-4a42-8db3-26ba9e9627e62
833082smallpox vaccine live, New York City Board of Health vaccinia strain 500000000 UNT/ML Injectable SolutionSCDf8b2634b-ccd7-4a42-8db3-26ba9e9627e62
833086ACAM2000 500000000 UNT/ML Injectable SolutionSYf8b2634b-ccd7-4a42-8db3-26ba9e9627e62
833086ACAM2000 smallpox (vaccinia) vaccine, live Injectable SolutionSYf8b2634b-ccd7-4a42-8db3-26ba9e9627e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71665-340-01716650340010.6 mL in 1 VIAL, GLASS0.6 mlHistorical
71665-340-027166503400250 in 1 CARTONHistorical
71665-340-03716650340038 CARTON in 1 CASE (71665-340-03) / 50 VIAL, GLASS in 1 CARTON (71665-340-02) / .6 mL in 1 VIAL, GLASS (71665-340-01) 8 carton2007-08-31NoNoCurrent