NDC 72000-030

Citric Buffered Normal Saline

Anhydrous Citric Acid

Citric Buffered Normal Saline is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nabriva Therapeutics Us, Inc.. The primary component is Anhydrous Citric Acid.

Product ID72000-030_5b6f16e1-384a-469f-91fe-9586625fce50
NDC72000-030
Product TypeHuman Prescription Drug
Proprietary NameCitric Buffered Normal Saline
Generic NameAnhydrous Citric Acid
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-09-09
Marketing CategoryNDA / NDA
Application NumberNDA211673
Labeler NameNabriva Therapeutics US, Inc.
Substance NameANHYDROUS CITRIC ACID
Active Ingredient Strength166 mg/270mL
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 Through2022-12-31

Packaging

NDC 72000-030-06

6 BAG in 1 CARTON (72000-030-06) > 270 mL in 1 BAG (72000-030-01)
Marketing Start Date2019-09-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72000-030-01 [72000003001]

Citric Buffered Normal Saline INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA211673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-09-09

NDC 72000-030-06 [72000003006]

Citric Buffered Normal Saline INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA211673
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-09-09

Drug Details

Active Ingredients

IngredientStrength
ANHYDROUS CITRIC ACID166 mg/270mL

OpenFDA Data

SPL SET ID:101db63d-2fe2-48df-8506-1382d6dcd4a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2198953
  • 2198966
  • 2198961
  • 2198948
  • UPC Code
  • 0372000110301
  • 0372000120065
  • Pharmacological Class

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

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