FDA.reportPublic FDA data

EMRELIS

Product NDC
0074-1044
11-digit product format
000741044
Labeler code
0074
Product ID
0074-1044_998985bb-7cd1-4e80-bd08-8fc7c503f982
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telisotuzumab Vedotin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
AbbVie Inc.
Application
BLA761384
Marketing category
BLA
Marketing start
2025-05-14
Substance
TELISOTUZUMAB VEDOTIN
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TELISOTUZUMAB VEDOTIN20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
976X9VXC3ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2714245Internal RxNorm lookup
2714251Internal RxNorm lookup
2714253Internal RxNorm lookup
2714255Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc04f980-3957-4e35-ab81-8ec2ffe87215Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14165bd1-2b3f-4875-a356-0c9eaecd234bProduct name120260303
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-1044-01EMRELIS1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13
0074-1044-01EMRELIS1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-1044-01EA - Each0074-10441a3eed32-83f8-4fb7-b9fd-6b47b3360bf912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-1044TELISOTUZUMAB VEDOTIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ABBVIE INC.]2Current NDC, 2 package rows20250516_bc04f980-3957-4e35-ab81-8ec2ffe87215.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
EMRELISTELISOTUZUMAB VEDOTINAbbVie Inc.bc04f980-3957-4e35-ab81-8ec2ffe872152025-05-25Warnings, Adverse reactionsExact identifier
application number: BLA761384
ndc (product): 0074-1044

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761384Emrelistelisotuzumab vedotin-tllv351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2714251Emrelis 100 MG InjectionPSNbc04f980-3957-4e35-ab81-8ec2ffe872153
2714255Emrelis 20 MG InjectionPSNbc04f980-3957-4e35-ab81-8ec2ffe872153
2714245telisotuzumab vedotin-tllv 100 MG InjectionPSNbc04f980-3957-4e35-ab81-8ec2ffe872153
2714253telisotuzumab vedotin-tllv 20 MG InjectionPSNbc04f980-3957-4e35-ab81-8ec2ffe872153
2714251telisotuzumab vedotin-tllv 100 MG Injection [Emrelis]SBDbc04f980-3957-4e35-ab81-8ec2ffe872153
2714255telisotuzumab vedotin-tllv 20 MG Injection [Emrelis]SBDbc04f980-3957-4e35-ab81-8ec2ffe872153
2714245telisotuzumab vedotin-tllv 100 MG InjectionSCDbc04f980-3957-4e35-ab81-8ec2ffe872153
2714253telisotuzumab vedotin-tllv 20 MG InjectionSCDbc04f980-3957-4e35-ab81-8ec2ffe872153
2714251Emrelis 100 MG InjectionSYbc04f980-3957-4e35-ab81-8ec2ffe872153
2714255Emrelis 20 MG InjectionSYbc04f980-3957-4e35-ab81-8ec2ffe872153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0074-1044-01000741044011 VIAL, SINGLE-DOSE in 1 CARTON (0074-1044-01) / 1 mL in 1 VIAL, SINGLE-DOSE2025-05-14NoNoCurrent