FDA.reportPublic FDA data

ELAHERE

Product NDC
72903-853
11-digit product format
729030853
Labeler code
72903
Product ID
72903-853_47f1c78d-c469-4cd7-926e-51ce5b2d26f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIRVETUXIMAB SORAVTANSINE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ImmunoGen, Inc.
Application
BLA761310
Marketing category
BLA
Marketing start
2022-11-14
Substance
MIRVETUXIMAB SORAVTANSINE
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELAHEREMIRVETUXIMAB SORAVTANSINEImmunoGen, Inc.00c424b5-6ccd-48ab-9e88-1986451120e22025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761310
ndc (product): 72903-853

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRVETUXIMAB SORAVTANSINE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98DE7VN88DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2621553Internal RxNorm lookup
2621559Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
00c424b5-6ccd-48ab-9e88-1986451120e2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
72903-853-01ELAHERE1 in 1 CARTONINJECTION, SOLUTION114
72903-853-01ELAHERE20 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION2014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72903-853-01ML - Milliliter72903-8533e00549c-10bb-439c-b794-3a343eca870c12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72903-853ELAHERE (MIRVETUXIMAB SORAVTANSINE) INJECTION, SOLUTION [IMMUNOGEN, INC.]11Current NDC, Legacy NDC, 2 package rows20241101_00c424b5-6ccd-48ab-9e88-1986451120e2.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761310Elaheremirvetuximab soravtansine-gynx351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2621559ELAHERE 100 MG in 20 ML InjectionPSN00c424b5-6ccd-48ab-9e88-1986451120e214
2621553mirvetuximab soravtansine-gynx 100 MG in 20 ML InjectionPSN00c424b5-6ccd-48ab-9e88-1986451120e214
262155920 ML mirvetuximab soravtansine-gynx 5 MG/ML Injection [Elahere]SBD00c424b5-6ccd-48ab-9e88-1986451120e214
262155320 ML mirvetuximab soravtansine-gynx 5 MG/ML InjectionSCD00c424b5-6ccd-48ab-9e88-1986451120e214
2621559Elahere 100 MG per 20 ML InjectionSY00c424b5-6ccd-48ab-9e88-1986451120e214
2621559Elahere 5 MG/ML per 20 ML InjectionSY00c424b5-6ccd-48ab-9e88-1986451120e214
2621553mirvetuximab soravtansine-gynx 100 MG per 20 ML InjectionSY00c424b5-6ccd-48ab-9e88-1986451120e214
2621553mirvetuximab soravtansine-gynx 5 MG/ML per 20 ML InjectionSY00c424b5-6ccd-48ab-9e88-1986451120e214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72903-853-01729030853011 VIAL, SINGLE-USE in 1 CARTON (72903-853-01) / 20 mL in 1 VIAL, SINGLE-USE2022-11-140000-00-00NoNoCurrent