Home NDC 14498-003 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 Ingredient Strength SODIUM CITRATE .92 g/35mL DEXTROSE MONOHYDRATE .89 g/35mL CITRIC ACID MONOHYDRATE 114.5 mg/35mL SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 87.9 mg/35mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 14498-003-01 Sterile Cord Blood Collection Unit (MSC127D) 35 mL in 1 KIT INJECTION, SOLUTION 35 4 14498-003-01 Sterile Cord Blood Collection Unit (MSC127D) 1 in 1 KIT INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14498-003 STERILE CORD BLOOD COLLECTION UNIT (MSC127D) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION) INJECTION, SOLUTION [MACO PRODUCTIONS] 3 Current NDC, Legacy NDC, 2 package rows 20180103_75a008b2-9666-4bfa-ab18-6d09b43b2215.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 14498-003-01 14498000301 1 KIT in 1 KIT (14498-003-01) / 35 mL in 1 KIT 1 kit 2016-12-21 0000-00-00 No No Current