Home NDC 72359-001-01 RETHYMIC
Product NDC 72359-001
Requested package NDC 72359-001-01
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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.
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 2026-09-01
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