Home NDC 71665-330 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71665-330-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71665-330-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71665-330-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71665-330-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71665-330-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71665-330-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71665-330-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base ACAM2000
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 100000000 [PFU]/mL
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71665-330-01 ACAM2000 0.3 mL in 1 VIAL, MULTI-DOSE INJECTION, POWDER, LYOPHILIZED, 0.3 2 71665-330-02 ACAM2000 50 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 50 2 71665-330-03 ACAM2000 8 in 1 CASE INJECTION, POWDER, LYOPHILIZED, 8 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71665-330 ACAM2000 (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.] 2 Current NDC, Legacy NDC, 3 package rows 20250328_f8b2634b-ccd7-4a42-8db3-26ba9e9627e6.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125158 Acam2000 Smallpox (Vaccinia) Vaccine, Live 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71665-330-01 71665033001 0.3 mL in 1 VIAL, MULTI-DOSE 0.3 ml Historical 71665-330-02 71665033002 50 VIAL, MULTI-DOSE in 1 CARTON (71665-330-02) > .3 mL in 1 VIAL, MULTI-DOSE (71665-330-01) 2007-08-31 0000-00-00 No No Current 71665-330-03 71665033003 8 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 carton 2007-08-31 No No Current