Home NDC 68152-103 Zevalin
Product NDC 68152-103
11-digit product format 681520103
Labeler code 68152
Product ID 68152-103_2783f9e8-22ed-4efb-9661-bb1ea9aba9aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ibritumomab tiuxetan
Dosage form KIT
Labeler Spectrum Pharmaceuticals, Inc.
Application BLA125019
Marketing category BLA
Marketing start 2002-02-19
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68152-103-03 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68152-103-03 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68152-103-03 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68152-103-03 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68152-103-03 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68152-103-03 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68152-103-03 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68152-103-03 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68152-103-03 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68152-103-03 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68152-103-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68152-103-03 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBRITUMOMAB TIUXETAN ACTIVE INGREDIENT 4Q52C550XK ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 IBRITUMOMAB TIUXETAN ACTIVE MOIETY 4Q52C550XK ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 ALBUMIN (HUMAN) INACTIVE INGREDIENT ZIF514RVZR ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 PENTETIC ACID INACTIVE INGREDIENT 7A314HQM0I ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE INACTIVE INGREDIENT E1W4N241FO ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R ZEVALIN (IBRITUMOMAB TIUXETAN) KIT [SPECTRUM PHARMACEUTICALS, INC.] 5
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zevalin IBRITUMOMAB TIUXETAN Acrotech Biopharma Inc 25d367dc-da65-44c9-a844-1bf15339c285 2023-04-25 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125019
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125019 Zevalin ibritumomab tiuxetan 351(a) Rx 2026-07-01