FDA.reportPublic FDA data

NDC 72359-001-02 - RETHYMIC

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
72359-001
Requested NDC
72359-001-02
Package NDCs from labels
72359-001-02, 72359-001-01
Manufacturer
Sumitomo Pharma America, Inc. | Sumitomo Pharma Switzerland GmbH
Effective date
2025-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RETHYMIC - Sumitomo Pharma America, Inc. | Sumitomo Pharma Switzerland GmbHSumitomo Pharma America, Inc. | Sumitomo Pharma Switzerland GmbH2025-10-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72359-001-01RETHYMIC11 in 1 BOXIMPLANT118
72359-001-02RETHYMIC4 in 1 CONTAINERIMPLANT48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72359-001RETHYMIC (ALLOGENIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDC) IMPLANT [SUMITOMO PHARMA AMERICA, INC.]7Current NDC, Legacy NDC, 2 package rows20250101_e0022c28-8cda-4f1e-bcf1-1f440d37ec4a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72359-001-01EA - Each72359-00106a43849-5e1a-4e0d-ab24-332524778a0712021-11-09

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RETHYMICALLOGENIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDCSumitomo Pharma America, Inc.e0022c28-8cda-4f1e-bcf1-1f440d37ec4a2025-10-31Warnings, Adverse reactionsExact identifier
application number: BLA125685
ndc (package): 72359-001-02
ndc (package): 72359-001-01
ndc (product): 72359-001
ndc11 (package): 72359000102
rxcui: 2626469
rxcui: 2626464
spl id: 6b1c53ef-4ff9-46ff-96ad-b0cb5609ec17
spl set id: e0022c28-8cda-4f1e-bcf1-1f440d37ec4a
unii: XD66YK3YY3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.