NDC 14498-003

Sterile Cord Blood Collection Unit (MSC127D)

Anticoagulant Citrate Phosphate Dextrose Solution

Sterile Cord Blood Collection Unit (MSC127D) is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Maco Productions. The primary component is Sodium Citrate; Dextrose Monohydrate; Citric Acid Monohydrate; Sodium Phosphate, Monobasic, Dihydrate.

• Product ID: 14498-003_034e4d21-9b5d-4316-b465-c7d89148729a
• NDC: 14498-003
• Product Type: Human Prescription Drug
• Proprietary Name: Sterile Cord Blood Collection Unit (MSC127D)
• Generic Name: Anticoagulant Citrate Phosphate Dextrose Solution
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-12-21
• Marketing Category: NDA / NDA
• Application Number: BN125552
• Labeler Name: Maco Productions
• Substance Name: SODIUM CITRATE; DEXTROSE MONOHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
• Active Ingredient Strength: 1 g/35mL; g/35mL; mg/35mL; mg/35mL
• Pharm Classes: Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 14498-003-01

1 KIT in 1 KIT (14498-003-01) > 35 mL in 1 KIT

• Marketing Start Date: 2016-12-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 14498-003-01 [14498000301]

Sterile Cord Blood Collection Unit (MSC127D) INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: BN125552
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-21

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM CITRATE	.92 g/35mL

OpenFDA Data

• SPL SET ID: 75a008b2-9666-4bfa-ab18-6d09b43b2215
• Manufacturer:
  • Maco Productions
• UNII:
  • 5QWK665956
  • 1Q73Q2JULR
  • 2968PHW8QP
  • LX22YL083G

Pharmacological Class

• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]
• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]
• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]
• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]

NDC Crossover Matching brand name "Sterile Cord Blood Collection Unit (MSC127D)" or generic name "Anticoagulant Citrate Phosphate Dextrose Solution"

NDC	Brand Name	Generic Name
14498-003	Sterile Cord Blood Collection Unit (MSC127D)	Anticoagulant Citrate Phosphate Dextrose Solution
14498-004	Sterile Cord Blood Collection Unit (MSC128D)	Anticoagulant Citrate Phosphate Dextrose Solution