NDC 63323-505

Sodium Citrate Blood-Pack Units, (PL 146 Plastic)

Anticoagulant Sodium Citrate Solution

Sodium Citrate Blood-Pack Units, (PL 146 Plastic) is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Trisodium Citrate Dihydrate.

• Product ID: 63323-505_006cef90-97b0-4f0b-9bc2-9d072bbda890
• NDC: 63323-505
• Product Type: Human Prescription Drug
• Proprietary Name: Sodium Citrate Blood-Pack Units, (PL 146 Plastic)
• Generic Name: Anticoagulant Sodium Citrate Solution
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-09-29
• Marketing Category: NDA / NDA
• Application Number: BN770923
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: TRISODIUM CITRATE DIHYDRATE
• Active Ingredient Strength: 4 g/100mL
• Pharm Classes: 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: 2019-12-31

Packaging

NDC 63323-505-74

250 mL in 1 BAG (63323-505-74)

• Marketing Start Date: 2014-09-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-505-74 [63323050574]

Sodium Citrate Blood Pack Units, (PL 146 Plastic) SOLUTION

• Marketing Category: NDA
• Application Number: BN770923
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-09-29

Drug Details

Active Ingredients

Ingredient	Strength
TRISODIUM CITRATE DIHYDRATE	4 g/100mL

OpenFDA Data

• SPL SET ID: ccec1a48-d2f4-4130-93d9-d68502321b1d
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • B22547B95K

Pharmacological Class

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

NDC Crossover Matching brand name "Sodium Citrate Blood-Pack Units, (PL 146 Plastic)" or generic name "Anticoagulant Sodium Citrate Solution"

NDC	Brand Name	Generic Name
0942-9502	Sodium Citrate Blood-Pack Units, (PL 146 Plastic)	Anticoagulant Sodium Citrate Solution
0942-9504	Sodium Citrate Blood-Pack Units, (PL 146 Plastic)	Anticoagulant Sodium Citrate Solution
0942-9505	Sodium Citrate Blood-Pack Units, (PL 146 Plastic)	Anticoagulant Sodium Citrate Solution
0942-9506	Sodium Citrate Blood-Pack Units, (PL 146 Plastic)	Anticoagulant Sodium Citrate Solution
63323-505	Sodium Citrate Blood-Pack Units, (PL 146 Plastic)	Anticoagulant Sodium Citrate Solution
53157-798	Sodium Citrate	Anticoagulant Sodium Citrate Solution