FDA.reportPublic FDA data

NDC 71665-330-01 - ACAM2000

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71665-330
Requested NDC
71665-330-01
Package NDCs from labels
71665-330-01, 71665-330-02, 71665-330-03
Manufacturer
Emergent Product Development Gaithersburg Inc.
Effective date
2025-02-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACAM2000 - Emergent Product Development Gaithersburg Inc.Emergent Product Development Gaithersburg Inc.2025-02-25VACCINE LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 23 of 69 · 1,369 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: 451W47IQ8X
BM Nat MurNATRIUM MURIATICUMBM Private Limited37b12318-dff9-e32a-e063-6394a90a18e82025-12-02WarningsExact identifier
unii: 451W47IQ8X
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARBM Private Limited37c27f80-7689-c5a1-e063-6294a90a619b2025-12-02WarningsExact identifier
unii: 451W47IQ8X
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist MeijerSODIUM CHLORIDEMeijer, Inc.445c8f4f-0519-0764-e063-6294a90a8b392025-12-01WarningsExact identifier
unii: 451W47IQ8X
BUDDATE INONOTUS OBLIQUUS WATER BRILLIANCE MASKBUTYLENE GLYCOL, GLYCERIN, INONOTUS OBLIQUUS (MUSHROOM) EXTRACTBUDDATE Co Ltd464988ad-557e-13f5-e054-00144ff8d46c2025-11-30WarningsExact identifier
unii: PDC6A3C0OX
BUDDATE LOTUS MOISTURE ESSENCEGLYCERIN, NIACINAMIDE, NELUMBO NUCIFERA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACTBUDDATE Co Ltd46499995-8b13-3e5c-e054-00144ff88e882025-11-30WarningsExact identifier
unii: PDC6A3C0OX
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
unii: 451W47IQ8X
Walgreens Sore Throat Cherry FlavorPHENOLWALGREEN COMPANYfe092017-1f3e-41f1-b718-e24de53cf2762025-11-26WarningsExact identifier
unii: 339NCG44TV
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X
Rain Daily Hydration and Comfort For Dry EyesGLYCERINRain Eye Drops, LLC31d7c204-fb74-fb28-e063-6294a90ab3302025-11-23WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.