FDA.reportPublic FDA data

mRESVIA

Product NDC
80777-345
11-digit product format
807770345
Labeler code
80777
Product ID
80777-345_42531fa9-5b49-4ebe-8117-ce2fd97c0c53
Type
VACCINE
Nonproprietary name
Respiratory Syncytial Virus Vaccine
Dosage form
SUSPENSION
Route
INTRAMUSCULAR
Labeler
Moderna US, INC.
Application
BLA125796
Marketing category
BLA
Marketing start
2024-05-31
Substance
RNA-100-AR02
Active strength
50 ug/.5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RNA-100-AR0250 ug/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80777-345-01mRESVIA0.5 mL in 1 SYRINGESUSPENSION0.55
80777-345-61mRESVIA10 in 1 CARTONSUSPENSION105
80777-345-62mRESVIA1 in 1 CARTONSUSPENSION15
80777-345-63mRESVIA2 in 1 CARTONSUSPENSION25
80777-345-89mRESVIA2 in 1 CARTONSUSPENSION25
80777-345-90mRESVIA1 in 1 CARTONSUSPENSION15
80777-345-96mRESVIA10 in 1 CARTONSUSPENSION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80777-345-01ML - Milliliter80777-345639c9de3-5187-4b1d-be42-2a6600e8468a12024-07-12
80777-345-61ML - Milliliter80777-345c4159982-34cb-4954-9d0c-44d72e764a2912025-09-12
80777-345-63ML - Milliliter80777-3451c997840-0d97-407f-bc70-517756e43a5c12025-09-12
80777-345-90ML - Milliliter80777-3457b14b36b-f28d-4ca3-bc22-d87db62aa2fd12024-07-12
80777-345-96ML - Milliliter80777-34594df3056-82b3-4035-9eee-12e64c1fb91712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80777-345MRESVIA (RESPIRATORY SYNCYTIAL VIRUS VACCINE) SUSPENSION [MODERNA US, INC.]4Current NDC, 7 package rows20241226_e5c837e7-41e8-496a-9c85-6b0453b35948.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125796mresviaRespiratory Syncytial Virus Vaccine351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2685012mRESVIA 50 MCG in 0.5 ML Prefilled SyringePSNe5c837e7-41e8-496a-9c85-6b0453b359485
2685006respiratory syncytial virus pre-fusion F glycoprotein mRNA 50 MCG in 0.5 ML Prefilled SyringePSNe5c837e7-41e8-496a-9c85-6b0453b359485
26850120.5 ML respiratory syncytial virus pre-fusion F glycoprotein mRNA 0.1 MG/ML Prefilled Syringe [Mresvia]SBDe5c837e7-41e8-496a-9c85-6b0453b359485
26850060.5 ML respiratory syncytial virus pre-fusion F glycoprotein mRNA 0.1 MG/ML Prefilled SyringeSCDe5c837e7-41e8-496a-9c85-6b0453b359485
26850120.5 ML Mresvia 0.1 MG/ML Prefilled SyringeSYe5c837e7-41e8-496a-9c85-6b0453b359485
2685012mRESVIA 50 MCG per 0.5 ML Prefilled SyringeSYe5c837e7-41e8-496a-9c85-6b0453b359485
2685006respiratory syncytial virus pre-fusion F glycoprotein mRNA 50 MCG per 0.5 ML Prefilled SyringeSYe5c837e7-41e8-496a-9c85-6b0453b359485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80777-345-01807770345010.5 mL in 1 SYRINGE0.5 mlHistorical
80777-345-618077703456110 SYRINGE in 1 CARTON (80777-345-61) / .5 mL in 1 SYRINGE (80777-345-01) 10 syringe2024-05-31NoNoCurrent
80777-345-62807770345621 SYRINGE in 1 CARTON (80777-345-62) / .5 mL in 1 SYRINGE (80777-345-01) 1 syringe2024-05-31NoNoCurrent
80777-345-63807770345632 SYRINGE in 1 CARTON (80777-345-63) / .5 mL in 1 SYRINGE (80777-345-01) 2 syringe2024-05-31NoNoCurrent
80777-345-89807770345892 SYRINGE in 1 CARTON (80777-345-89) / .5 mL in 1 SYRINGE (80777-345-01) 2 syringe2024-05-31NoNoCurrent
80777-345-90807770345901 SYRINGE in 1 CARTON (80777-345-90) / .5 mL in 1 SYRINGE (80777-345-01) 1 syringe2024-05-31NoNoCurrent
80777-345-968077703459610 SYRINGE in 1 CARTON (80777-345-96) / .5 mL in 1 SYRINGE (80777-345-01) 10 syringe2024-05-31NoNoCurrent