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 ID63323-505_006cef90-97b0-4f0b-9bc2-9d072bbda890
NDC63323-505
Product TypeHuman Prescription Drug
Proprietary NameSodium Citrate Blood-Pack Units, (PL 146 Plastic)
Generic NameAnticoagulant Sodium Citrate Solution
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-09-29
Marketing CategoryNDA / NDA
Application NumberBN770923
Labeler NameFresenius Kabi USA, LLC
Substance NameTRISODIUM CITRATE DIHYDRATE
Active Ingredient Strength4 g/100mL
Pharm ClassesAcidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-505-74

250 mL in 1 BAG (63323-505-74)
Marketing Start Date2014-09-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-505-74 [63323050574]

Sodium Citrate Blood Pack Units, (PL 146 Plastic) SOLUTION
Marketing CategoryNDA
Application NumberBN770923
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-09-29

Drug Details

Active Ingredients

IngredientStrength
TRISODIUM CITRATE DIHYDRATE4 g/100mL

OpenFDA Data

SPL SET ID:ccec1a48-d2f4-4130-93d9-d68502321b1d
Manufacturer
UNII

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"

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.