Home NDC 72359-001 RETHYMIC
Product NDC 72359-001
11-digit product format 723590001
Labeler code 72359
Product ID 72359-001_6b1c53ef-4ff9-46ff-96ad-b0cb5609ec17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name allogenic thymocyte-depleted thymus tissue-agdc
Dosage form IMPLANT
Route INTRAMUSCULAR
Labeler Sumitomo Pharma America, Inc.
Application BLA125685
Marketing category BLA
Marketing start 2021-10-08
Substance ALLOGENEIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDC
Active strength 22000 mm/1
NDC exclude flag No
Listing certified through 2026-12-31
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RETHYMIC ALLOGENIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDC Sumitomo Pharma America, Inc. e0022c28-8cda-4f1e-bcf1-1f440d37ec4a 2025-10-31 Warnings, Adverse reactions Exact identifier application number: BLA125685 ndc (product): 72359-001
Additional Listing Data#
Finished product Yes
Brand name base RETHYMIC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLOGENEIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDC 22000 mm/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XD66YK3YY3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2626464 Internal RxNorm lookup 2626469 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72359-001-01 RETHYMIC 11 in 1 BOX IMPLANT 11 8 72359-001-02 RETHYMIC 4 in 1 CONTAINER IMPLANT 4 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72359-001 RETHYMIC (ALLOGENIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDC) IMPLANT [SUMITOMO PHARMA AMERICA, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20250101_e0022c28-8cda-4f1e-bcf1-1f440d37ec4a.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125685 Rethymic allogeneic processed thymus tissue-agdc 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72359-001-01 72359000101 11 CONTAINER in 1 BOX (72359-001-01) / 4 IMPLANT in 1 CONTAINER (72359-001-02) 11 container 2021-10-08 0000-00-00 No No Current 72359-001-02 72359000102 4 in 1 CONTAINER Historical