FDA.reportPublic FDA data

ACAM2000

Product NDC
71665-330
11-digit product format
716650330
Labeler code
71665
Product ID
71665-330_52ed1149-d6e1-49af-bae5-96b9d248009c
Type
VACCINE
Nonproprietary name
smallpox and mpox (vaccinia) vaccine, live
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
PERCUTANEOUS
Labeler
Emergent Product Development Gaithersburg Inc.
Application
BLA125158
Marketing category
BLA
Marketing start
2007-08-31
Substance
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN
Active strength
100000000 [PFU]/mL
Pharmacologic classes
Actively Acquired Immunity [PE], Live Vaccinia Virus Vaccine [EPC], Smallpox Vaccine [CS], Vaccines, Live, Unattenuated [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN100000000 [PFU]/mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71665-330-022025-03-27C16284748780-12cef2736-62c4-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ACAM2000 safely and effectively. See full prescribing information for ACAM2000. ACAM2000 ® [Smallpox and Mpox (Vaccinia) Vaccine, Live] For scarification suspension, for percutaneous use Initial U.S. Approval: 2007
71665-330-022025-01-30C16284748780-12cef2736-62c4-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ACAM2000 safely and effectively. See full prescribing information for ACAM2000. ACAM2000 ® [Smallpox and Mpox (Vaccinia) Vaccine, Live] For scarification suspension, for percutaneous use Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71665-330-01ACAM20000.3 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,0.32
71665-330-02ACAM200050 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,502
71665-330-03ACAM20008 in 1 CASEINJECTION, POWDER, LYOPHILIZED,82

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71665-330-01EA - Each71665-33091fb2708-0c18-4a3c-9fd2-d55c7775ec2712022-07-06
71665-330-02EA - Each71665-3303b75da1e-399d-45fa-8312-a69a4ab5829d12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71665-330ACAM2000 (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, Legacy 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 startMarketing endSampleExclude flagStatus
71665-330-01716650330010.3 mL in 1 VIAL, MULTI-DOSE0.3 mlHistorical
71665-330-027166503300250 VIAL, MULTI-DOSE in 1 CARTON (71665-330-02) > .3 mL in 1 VIAL, MULTI-DOSE (71665-330-01) 2007-08-310000-00-00NoNoCurrent
71665-330-03716650330038 CARTON in 1 CASE (71665-330-03) / 50 VIAL, MULTI-DOSE in 1 CARTON (71665-330-02) / .3 mL in 1 VIAL, MULTI-DOSE (71665-330-01) 8 carton2007-08-31NoNoHistorical