FDA.reportPublic FDA data

HemaCord

Product NDC
76489-001
Requested package NDC
76489-001-02
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76489-00176489-001-02IInactivated by FDA2026-08-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76489-001-022025-01-30C16284748780-12cef2736-6f55-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use HEMACORD safely and effectively. See full prescribing information for HEMACORD. HEMACORD (HPC, Cord Blood) Injectable Suspension for Intravenous Use Initial U.S. Approval: 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76489-001-01HemaCord25 mL in 1 BAGINJECTION259
76489-001-02HemaCord1 in 1 CANISTERINJECTION19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELLACTIVE INGREDIENTXU53VK93MCHEMACORD (HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL) INJECTION [NEW YORK BLOOD CENTER]5
HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELLACTIVE MOIETYXU53VK93MCHEMACORD (HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL) INJECTION [NEW YORK BLOOD CENTER]5
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698HHEMACORD (HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL) INJECTION [NEW YORK BLOOD CENTER]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76489-001HEMACORD (HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL) INJECTION [NEW YORK BLOOD CENTER]9Legacy NDC, 2 package rows20221020_bd9a5180-1773-11e0-980a-0002a5d5c51b.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125397HemacordHematopoietic Progenitor Cells, Cord (HPC-C)351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76489-001-02764890001021 BAG in 1 CANISTER (76489-001-02) > 25 mL in 1 BAG (76489-001-01) 1 bag2011-11-100000-00-00NoNoCurrent