FDA.reportPublic FDA data

IMDELLTRA (AMG757)

Product NDC
55513-059
11-digit product format
555130059
Labeler code
55513
Product ID
55513-059_2e2c9381-efd5-4804-aa85-cff5ee5d10ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tarlatamab-dlle
Dosage form
KIT
Labeler
Amgen, Inc
Application
BLA761344
Marketing category
BLA
Marketing start
2024-05-16
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IMDELLTRA (AMG757)
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2682961Internal RxNorm lookup
2682967Internal RxNorm lookup
2682969Internal RxNorm lookup
2682971Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e7b6163-5d83-42ea-82c9-cf7620cdc782Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b06db7e9-a26d-4498-85da-7ac8c27a5bbaProduct name120250221
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-059-01IMDELLTRA (AMG757)1 in 1 PACKAGEKIT15
55513-103-01IMDELLTRA (AMG757)1 mg in 1 VIALINJECTION, POWDER, LYOPHILIZED,1 mg0.9 mg in 1mg5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-059-01EA - Each55513-0594a4ea823-a89b-4cc3-988a-bf0a981549e012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-059IMDELLTRA (AMG757) (TARLATAMAB-DLLE) KIT [AMGEN INC]3Current NDC, 2 package rows20240718_1e7b6163-5d83-42ea-82c9-cf7620cdc782.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
IMDELLTRA (AMG757)TARLATAMAB-DLLEAmgen, Inc1e7b6163-5d83-42ea-82c9-cf7620cdc7822026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761344
ndc (product): 55513-059

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761344Imdelltratarlatamab-dlle351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2682967IMDELLTRA 1 MG InjectionPSN1e7b6163-5d83-42ea-82c9-cf7620cdc7825
2682971IMDELLTRA 10 MG InjectionPSN1e7b6163-5d83-42ea-82c9-cf7620cdc7825
2682961tarlatamab-dlle 1 MG InjectionPSN1e7b6163-5d83-42ea-82c9-cf7620cdc7825
2682969tarlatamab-dlle 10 MG InjectionPSN1e7b6163-5d83-42ea-82c9-cf7620cdc7825
2682967tarlatamab-dlle 1 MG Injection [Imdelltra]SBD1e7b6163-5d83-42ea-82c9-cf7620cdc7825
2682971tarlatamab-dlle 10 MG Injection [Imdelltra]SBD1e7b6163-5d83-42ea-82c9-cf7620cdc7825
2682961tarlatamab-dlle 1 MG InjectionSCD1e7b6163-5d83-42ea-82c9-cf7620cdc7825
2682969tarlatamab-dlle 10 MG InjectionSCD1e7b6163-5d83-42ea-82c9-cf7620cdc7825
2682967Imdelltra 1 MG InjectionSY1e7b6163-5d83-42ea-82c9-cf7620cdc7825
2682971Imdelltra 10 MG InjectionSY1e7b6163-5d83-42ea-82c9-cf7620cdc7825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55513-059-01555130059011 KIT in 1 PACKAGE (55513-059-01) * 1 mg in 1 VIAL (55513-103-01) * 7 mL in 1 VIAL (55513-068-01) 1 kit2024-05-16NoNoCurrent
55513-103-01555130103011 mg in 1 VIAL1 mgHistorical