FDA.reportPublic FDA data

Imlygic

Product NDC
55513-078
11-digit product format
555130078
Labeler code
55513
Product ID
55513-078_4d1843a8-7a83-4062-ba8c-4f97e2f1427b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
talimogene laherparepvec
Dosage form
INJECTION, SUSPENSION
Route
INTRALESIONAL
Labeler
Amgen Inc
Application
BLA125518
Marketing category
BLA
Marketing start
2015-11-02
Substance
TALIMOGENE LAHERPAREPVEC
Active strength
1000000 [PFU]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imlygic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TALIMOGENE LAHERPAREPVEC1000000 [PFU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
07730V90L6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1721278Internal RxNorm lookup
1721283Internal RxNorm lookup
1721287Internal RxNorm lookup
1721289Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64ffb680-ea8c-42fc-9649-9e8c0eb77ddbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-078-01Imlygic1 in 1 CARTONINJECTION, SUSPENSION127
55513-078-01Imlygic1 mL in 1 VIALINJECTION, SUSPENSION127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-078-01ML - Milliliter55513-07857948d31-0764-41ac-a4f7-ffaad84cdb4912015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TALIMOGENE LAHERPAREPVECACTIVE INGREDIENT07730V90L6IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC]4
TALIMOGENE LAHERPAREPVECACTIVE MOIETY07730V90L6IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC]4
INOSITOLINACTIVE INGREDIENT4L6452S749IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XIMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC]4
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TIMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC]4
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK665956IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC]4
SORBITOLINACTIVE INGREDIENT506T60A25RIMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC]4
WATERINACTIVE INGREDIENT059QF0KO0RIMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-078IMLYGIC (TALIMOGENE LAHERPAREPVEC) INJECTION, SUSPENSION [AMGEN INC]27Current NDC, Legacy NDC, 2 package rows20250418_64ffb680-ea8c-42fc-9649-9e8c0eb77ddb.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
ImlygicTALIMOGENE LAHERPAREPVECAmgen Inc64ffb680-ea8c-42fc-9649-9e8c0eb77ddb2025-04-04Warnings, Adverse reactionsExact identifier
application number: BLA125518
ndc (product): 55513-078

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125518ImlygicTalimogene laherparepvec351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721283IMLYGIC 1,000,000 PFU in 1 mL InjectionPSN64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
1721289IMLYGIC 100,000,000 PFU in 1 mL InjectionPSN64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
1721278talimogene laherparepvec 1,000,000 PFU in 1 mL InjectionPSN64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
1721287talimogene laherparepvec 100,000,000 PFU in 1 mL InjectionPSN64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
17212831 ML talimogene laherparepvec 1000000 UNT/ML Injection [Imlygic]SBD64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
17212891 ML talimogene laherparepvec 100000000 UNT/ML Injection [Imlygic]SBD64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
17212781 ML talimogene laherparepvec 1000000 UNT/ML InjectionSCD64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
17212871 ML talimogene laherparepvec 100000000 UNT/ML InjectionSCD64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
17212831 ML Imlygic 1000000 UNT/ML InjectionSY64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
17212891 ML Imlygic 100000000 UNT/ML InjectionSY64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
1721283Imlygic 1,000,000 PFU per 1 ML InjectionSY64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
1721289Imlygic 100,000,000 PFU per 1 ML InjectionSY64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
1721278talimogene laherparepvec 1,000,000 PFU per 1 ML InjectionSY64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27
1721287talimogene laherparepvec 100,000,000 PFU per 1 ML InjectionSY64ffb680-ea8c-42fc-9649-9e8c0eb77ddb27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-078-01555130078011 VIAL in 1 CARTON (55513-078-01) / 1 mL in 1 VIAL1 vial2015-11-020000-00-00NoNoCurrent