FDA.reportPublic FDA data

FluMist

Product NDC
66019-113
11-digit product format
660190113
Labeler code
66019
Product ID
66019-113_675ce8ee-acfe-4774-b6b8-c4950e0c071e
Type
VACCINE
Nonproprietary name
Influenza Vaccine Live Intranasal
Dosage form
SPRAY
Route
NASAL
Application
BLA125020
Marketing category
BLA
Marketing start
2026-07-22
Substance
INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1369/2025 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/PERTH/115/2025 LIVE (ATTENUATED) ANTIGEN
Active strength
10000000 [FFU]/.2mL
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/SWITZERLAND/6849/2025 (H1N1) LIVE (ATTENUATED) ANTIGEN10000000 [FFU]/.2mL
INFLUENZA A VIRUS A/DARWIN/1369/2025 (H3N2) LIVE (ATTENUATED) ANTIGEN10000000 [FFU]/.2mL
INFLUENZA B VIRUS B/PERTH/115/2025 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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125020Flumist, Flumist QuadInfluenza Vaccine Live, Intranasal351(a)Rx2026-06-01

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 startSampleStatus
66019-113-106601901131010 APPLICATOR in 1 CARTON (66019-113-10) / .2 mL in 1 APPLICATOR (66019-113-00)10 applicator2026-07-220Current
66019-113-51660190113511 APPLICATOR in 1 CARTON (66019-113-51) / .2 mL in 1 APPLICATOR (66019-113-00)1 applicator2026-07-220Current