FDA.reportPublic FDA data

FluMist

Product NDC
66019-112
11-digit product format
660190112
Labeler code
66019
Product ID
66019-112_3f8ad6e9-2f82-4014-b78a-9baf122b7956
Type
VACCINE
Nonproprietary name
Influenza Vaccine Live Intranasal
Dosage form
SPRAY
Route
NASAL
Labeler
MedImmune, LLC
Application
BLA125020
Marketing category
BLA
Marketing start
2025-08-01
Substance
INFLUENZA A VIRUS A/NORWAY/31694/2022 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/PERTH/722/2024 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 LIVE (ATTENUATED) ANTIGEN
Active strength
10000000; 10000000; 10000000 [FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLUENZA A VIRUS A/NORWAY/31694/2022 (H1N1) LIVE (ATTENUATED) ANTIGEN10000000 [FFU]/.2mL
INFLUENZA A VIRUS A/PERTH/722/2024 (H3N2) LIVE (ATTENUATED) ANTIGEN10000000 [FFU]/.2mL
INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 LIVE (ATTENUATED) ANTIGEN10000000 [FFU]/.2mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66019-112-00FluMist0.2 mL in 1 APPLICATORSPRAY0.25
66019-112-10FluMist10 in 1 CARTONSPRAY105
66019-112-51FluMist1 in 1 CARTONSPRAY15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66019-112-00EA - Each66019-112c5c784dc-0d1d-4247-bd88-cd1de040b90612025-08-11
66019-112-10EA - Each66019-1124f2c306c-e78d-4076-a28f-37c5bed47f9812025-08-11
66019-112-51EA - Each66019-112f4f6cb4c-0bbc-4053-96c6-d680a31a619b12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2720402FluMist 2025-2026 Formula Nasal SprayPSNb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720400FluMist 2025-2026 Formula Nasal Spray (Home Administration)PSNb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720401influenza virus vaccine 2025-2026 Nasal SprayPSNb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720398influenza virus vaccine 2025-2026 Nasal Spray (Home Administration)PSNb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720400Home Admin influenza A virus A/Norway/31694/2022 (H1N1) antigen 158000000 UNT/ML / influenza A virus A/Perth/722/2024 (H3N2) antigen 158000000 UNT/ML / influenza B virus B/Austria/1359417/2021 antigen 158000000 UNT/ML Nasal Spray [FluMist 2025-2026]SBDb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720402influenza A virus A/Norway/31694/2022 (H1N1) antigen 158000000 UNT/ML / influenza A virus A/Perth/722/2024 (H3N2) antigen 158000000 UNT/ML / influenza B virus B/Austria/1359417/2021 antigen 158000000 UNT/ML Nasal Spray [FluMist 2025-2026]SBDb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720398Home Admin influenza A virus A/Norway/31694/2022 (H1N1) antigen 158000000 UNT/ML / influenza A virus A/Perth/722/2024 (H3N2) antigen 158000000 UNT/ML / influenza B virus B/Austria/1359417/2021 antigen 158000000 UNT/ML Nasal SpraySCDb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720401influenza A virus A/Norway/31694/2022 (H1N1) antigen 158000000 UNT/ML / influenza A virus A/Perth/722/2024 (H3N2) antigen 158000000 UNT/ML / influenza B virus B/Austria/1359417/2021 antigen 158000000 UNT/ML Nasal SpraySCDb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720402FluMist 2025-2026 Formula Nasal SpraySYb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720400FluMist 2025-2026 Formula Nasal Spray (Home Administration)SYb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720401influenza virus vaccine 2025-2026 Nasal SpraySYb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15
2720398influenza virus vaccine 2025-2026 Nasal Spray (Home Administration)SYb8f34cfb-ee00-4b4a-aff8-643fe6f1d9e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66019-112-00660190112000.2 mL in 1 APPLICATOR0.2 mlHistorical
66019-112-106601901121010 APPLICATOR in 1 CARTON (66019-112-10) / .2 mL in 1 APPLICATOR (66019-112-00) 10 applicator2025-08-01NoNoHistorical
66019-112-51660190112511 APPLICATOR in 1 CARTON (66019-112-51) / .2 mL in 1 APPLICATOR (66019-112-00) 1 applicator2025-08-01NoNoHistorical