FDA.reportPublic FDA data

Synagis

Product NDC
66658-231
Requested package NDC
66658-231-01
11-digit product format
666580231
Labeler code
66658
Product ID
66658-231_2f379d7b-dcfd-4629-b14c-2f1d37891f7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
palivizumab
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Swedish Orphan Biovitrum AB (publ)
Application
BLA103770
Marketing category
BLA
Marketing start
1998-06-19
Marketing end
0000-00-00
Substance
PALIVIZUMAB
Active strength
100 mg/mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Fusion Protein Inhibitors [MoA], Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66658-23166658-231-01DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66658-231-01Synagis1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66658-231-01ML - Milliliter66658-23101097c0b-1d81-4c05-a292-9ab76b33fe4d12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66658-231SYNAGIS (PALIVIZUMAB) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]5Legacy NDC, 1 package rows20220329_3a0096c7-8139-44cd-bba4-520ab05c2cb2.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SynagisPALIVIZUMABSwedish Orphan Biovitrum AB (publ)3a0096c7-8139-44cd-bba4-520ab05c2cb22026-01-21Warnings, Adverse reactionsExact identifier
application number: BLA103770
ndc (package): 66658-231-01
ndc (product): 66658-231
ndc11 (package): 66658023101

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103770Synagispalivizumab351(a)Disc2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657341palivizumab 100 MG in 1 ML InjectionPSN3a0096c7-8139-44cd-bba4-520ab05c2cb28
1657361palivizumab 50 MG in 0.5 ML InjectionPSN3a0096c7-8139-44cd-bba4-520ab05c2cb28
1657343Synagis 100 MG in 1 ML InjectionPSN3a0096c7-8139-44cd-bba4-520ab05c2cb28
1657362Synagis 50 MG in 0.5 ML InjectionPSN3a0096c7-8139-44cd-bba4-520ab05c2cb28
16573620.5 ML palivizumab 100 MG/ML Injection [Synagis]SBD3a0096c7-8139-44cd-bba4-520ab05c2cb28
16573431 ML palivizumab 100 MG/ML Injection [Synagis]SBD3a0096c7-8139-44cd-bba4-520ab05c2cb28
16573610.5 ML palivizumab 100 MG/ML InjectionSCD3a0096c7-8139-44cd-bba4-520ab05c2cb28
16573411 ML palivizumab 100 MG/ML InjectionSCD3a0096c7-8139-44cd-bba4-520ab05c2cb28
1657341palivizumab 100 MG per 1 ML InjectionSY3a0096c7-8139-44cd-bba4-520ab05c2cb28
1657361palivizumab 50 MG per 0.5 ML InjectionSY3a0096c7-8139-44cd-bba4-520ab05c2cb28
1657343Synagis 100 MG per 1 ML InjectionSY3a0096c7-8139-44cd-bba4-520ab05c2cb28
1657362Synagis 50 MG per 0.5 ML InjectionSY3a0096c7-8139-44cd-bba4-520ab05c2cb28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66658-231-01666580231011 mL in 1 VIAL, SINGLE-DOSE (66658-231-01) 1 ml2005-09-280000-00-00NoNoCurrent