FDA.reportPublic FDA data

Sterile Cord Blood Collection Unit (MSC128D)

Product NDC
14498-004
Requested package NDC
14498-004-01
11-digit product format
144980004
Labeler code
14498
Product ID
14498-004_039ff6b2-3af3-43c7-8db6-922e2b6815ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anticoagulant Citrate Phosphate Dextrose Solution
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Maco Productions
Application
BN125552
Marketing category
NDA
Marketing start
2016-12-21
Substance
SODIUM CITRATE; DEXTROSE MONOHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
Active strength
.76; .74; 94.8; 72.8 g/29mL; g/29mL; mg/29mL; mg/29mL
Pharmacologic classes
Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]
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
Sterile Cord Blood Collection Unit (MSC128D)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CITRATE.76 g/29mL
DEXTROSE MONOHYDRATE.74 g/29mL
CITRIC ACID MONOHYDRATE94.8 mg/29mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE72.8 mg/29mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1Q73Q2JULRInternal UNII lookup
LX22YL083GInternal UNII lookup
2968PHW8QPInternal UNII lookup
5QWK665956Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251fd4cb-4aa4-4473-9f89-968da856eb77Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14498-004-01Sterile Cord Blood Collection Unit (MSC128D)29 mL in 1 KITINJECTION, SOLUTION294
14498-004-01Sterile Cord Blood Collection Unit (MSC128D)1 in 1 KITINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14498-004STERILE CORD BLOOD COLLECTION UNIT (MSC128D) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION) INJECTION, SOLUTION [MACO PRODUCTIONS]2Current NDC, Legacy NDC, 2 package rows20171222_251fd4cb-4aa4-4473-9f89-968da856eb77.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
application number: BN125552
ndc (package): 14498-004-01
ndc (product): 14498-004
ndc11 (package): 14498000401
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
application number: BN125552
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
application number: BN125552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14498-004-01144980004011 KIT in 1 KIT (14498-004-01) / 29 mL in 1 KIT1 kit2016-12-210000-00-00NoNoCurrent