NDC 0941-0487

DIANEAL Low Calcium with Dextrose

Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose

DIANEAL Low Calcium with Dextrose is a Intraperitoneal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Calcium Chloride; Dextrose Monohydrate; Magnesium Chloride; Sodium Chloride; Sodium Lactate.

Product ID0941-0487_1bac9069-af32-4e88-9d96-bf4006f0729f
NDC0941-0487
Product TypeHuman Prescription Drug
Proprietary NameDIANEAL Low Calcium with Dextrose
Generic NameSodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose
Dosage FormInjection, Solution
Route of AdministrationINTRAPERITONEAL
Marketing Start Date1978-09-27
Marketing CategoryNDA / NDA
Application NumberNDA017512
Labeler NameBaxter Healthcare Corporation
Substance NameCALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active Ingredient Strength18 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL
Pharm ClassesAcidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0941-0487-01

5000 mL in 1 BAG (0941-0487-01)
Marketing Start Date1978-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0941-0487-01 [00941048701]

DIANEAL Low Calcium with Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1978-09-27

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE2.5 g/100mL

OpenFDA Data

SPL SET ID:aa268d3f-7389-4f25-801f-5d4825495f08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 800472
  • 800057
  • 800064
  • 800066
  • 800061
  • 800062
  • 800074
  • 799999
  • 800111
  • 800474
  • 800003
  • 800115
  • Pharmacological Class

    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Blood Coagulation Factor [EPC]
    • Increased Coagulation Factor Activity [PE]
    • Calcium [CS]
    • Cations
    • Divalent [CS]
    • Calculi Dissolution Agent [EPC]
    • Magnesium Ion Exchange Activity [MoA]
    • Osmotic Laxative [EPC]
    • Osmotic Activity [MoA]
    • Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
    • Increased Large Intestinal Motility [PE]
    • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]

    NDC Crossover Matching brand name "DIANEAL Low Calcium with Dextrose" or generic name "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose"

    NDCBrand NameGeneric Name
    0941-0409DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
    0941-0424DIANEAL Low Calcium with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
    0941-0433DIANEAL Low Calcium with DextroseDIANEAL Low Calcium with Dextrose
    0941-0490DIANEAL Low Calcium with DextroseDIANEAL Low Calcium with Dextrose
    0941-0457DIANEAL Low Calcium with DextroseDIANEAL Low Calcium with Dextrose
    0941-0459DIANEAL Low Calcium with DextroseDIANEAL Low Calcium with Dextrose
    0941-0484DIANEAL Low Calcium with DextroseDIANEAL Low Calcium with Dextrose
    0941-0430DIANEAL Low Calcium with DextroseDIANEAL Low Calcium with Dextrose
    0941-0487DIANEAL Low Calcium with DextroseDIANEAL Low Calcium with Dextrose
    0941-0411DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
    0941-0413DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
    0941-0415DIANEAL PD-2 with Dextrosesodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

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