Home NDC 79403-791 Pall Sterile Cord Blood Collection Unit
Product NDC 79403-791
11-digit product format 794030791
Labeler code 79403
Product ID 79403-791_46366161-f003-2826-e063-6394a90a91a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sterile Cord Blood Collection Unit
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Global Life Sciences Solutions USA LLC
Application BN800222
Marketing category NDA
Marketing start 2025-12-18
Substance SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE
Active strength .921; .114; .0078; .893 g/35mL; g/35mL; g/35mL; g/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 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 Pall Sterile Cord Blood Collection Unit
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CITRATE .921 g/35mL CITRIC ACID MONOHYDRATE .114 g/35mL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .0078 g/35mL DEXTROSE MONOHYDRATE .893 g/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 79403-791-08 Pall Sterile Cord Blood Collection Unit 35 mL in 1 BAG SOLUTION 35 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79403-791 PALL STERILE CORD BLOOD COLLECTION UNIT (STERILE CORD BLOOD COLLECTION UNIT) SOLUTION [GLOBAL LIFE SCIENCES SOLUTIONS USA LLC] 5 Current NDC, Legacy NDC, 1 package rows 20250108_aa9340b7-cc63-e17d-e053-2a95a90ad4d9.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 · 1 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 79403-791-01 79403079101 35 mL in 1 BAG (79403-791-01) 35 ml 2011-03-16 0000-00-00 No No Current 79403-791-08 79403079108 35 mL in 1 BAG (79403-791-08) 35 ml 2025-12-18 No No Current