FDA.reportPublic FDA data

Zevalin

Product NDC
72893-007
11-digit product format
728930007
Labeler code
72893
Product ID
72893-007_c1ec6e37-45bb-4cda-a821-464552c48982
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibritumomab tiuxetan
Dosage form
KIT
Labeler
Acrotech Biopharma Inc
Application
BLA125019
Marketing category
BLA
Marketing start
2002-02-19
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25d367dc-da65-44c9-a844-1bf15339c285Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72893-007-042023-04-21C16284748780-1f386c649-bddd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZEVALIN safely and effectively. See full prescribing information for ZEVALIN. ZEVALIN® (ibritumomab tiuxetan) injection, for intravenous use Initial U.S. Approval: 2002
72893-007-042023-01-30C16284748780-1f386c649-bddd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZEVALIN safely and effectively. See full prescribing information for ZEVALIN. ZEVALIN® (ibritumomab tiuxetan) injection, for intravenous use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72893-007-04Zevalin1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72893-007-04EA - Each72893-007df24fe4c-5627-4180-8673-fa75b06d1d5812020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72893-007ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [ACROTECH BIOPHARMA INC]3Current NDC, Legacy NDC, 1 package rows20230426_25d367dc-da65-44c9-a844-1bf15339c285.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
ZevalinIBRITUMOMAB TIUXETANAcrotech Biopharma Inc25d367dc-da65-44c9-a844-1bf15339c2852023-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125019
ndc (product): 72893-007

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125019Zevalinibritumomab tiuxetan351(a)Rx2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72893-007-04728930007041 KIT in 1 CARTON (72893-007-04) * 10 mL in 1 VIAL * 2 mL in 1 VIAL * 2 mL in 1 VIAL1 kit2002-02-190000-00-00NoNoCurrent