Sterile Cord Blood Collection Unit (MSC127D)

Product NDC
14498-003
11-digit product format
144980003
Labeler code
14498
Product ID
14498-003_1a739084-4165-48f8-80a9-6b6073f18085
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
CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
Active strength
114.5; .89; .92; 87.9 mg/35mL; g/35mL; g/35mL; mg/35mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Sterile Cord Blood Collection Unit (MSC127D)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRIC ACID MONOHYDRATE114.5 mg/35mL
DEXTROSE MONOHYDRATE.89 g/35mL
SODIUM CITRATE.92 g/35mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE87.9 mg/35mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2968PHW8QP, LX22YL083G, 1Q73Q2JULR, 5QWK665956

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
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
14498-003-01Sterile Cord Blood Collection Unit (MSC127D)35 mL in 1 KITINJECTION, SOLUTION354
14498-003-01Sterile Cord Blood Collection Unit (MSC127D)1 in 1 KITINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14498-003STERILE CORD BLOOD COLLECTION UNIT (MSC127D) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION) INJECTION, SOLUTION [MACO PRODUCTIONS]3Current NDC, Legacy NDC, 2 package rows20180103_75a008b2-9666-4bfa-ab18-6d09b43b2215.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14498-003-01144980003011 KIT in 1 KIT (14498-003-01) / 35 mL in 1 KIT1 kit2016-12-210000-00-00NoNoCurrent