Home NDC 76489-001 HemaCord
Product NDC 76489-001
11-digit product format 764890001
Labeler code 76489
Product ID 76489-001_eb63d261-e74f-f8fa-e053-2a95a90a538a
Type CELLULAR THERAPY
Nonproprietary name HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL
Dosage form INJECTION
Route INTRAVENOUS
Labeler New York Blood Center
Application BLA125397
Marketing category BLA
Marketing start 2011-11-10
Marketing end 0000-00-00
Substance HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL
Active strength 500000000 1/25mL
Pharmacologic classes Allogeneic Cord Blood Hematopoietic Progenitor Cell Therapy [EPC], Cells, Allogeneic [EXT], Hematopoietic Stem Cells [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 76489-001-02 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 76489-001-02 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76489-001-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76489-001-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76489-001-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76489-001-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76489-001-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76489-001-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76489-001-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76489-001-01 HemaCord 25 mL in 1 BAG INJECTION 25 9 76489-001-02 HemaCord 1 in 1 CANISTER INJECTION 1 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76489-001 HEMACORD (HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL) INJECTION [NEW YORK BLOOD CENTER] 9 Legacy NDC, 2 package rows 20221020_bd9a5180-1773-11e0-980a-0002a5d5c51b.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125397 Hemacord Hematopoietic Progenitor Cells, Cord (HPC-C) 351(a) Rx 2026-09-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76489-001-01 76489000101 25 mL in 1 BAG 25 ml Historical 76489-001-02 76489000102 1 BAG in 1 CANISTER (76489-001-02) > 25 mL in 1 BAG (76489-001-01) 1 bag 2011-11-10 0000-00-00 No No Current