NDC 70529-027

Lacellate Solution - 1000

Sodium Chloride, Potassium Chloride, Sodium Lactate And Calcium Chloride

Lacellate Solution - 1000 is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by It3 Medical Llc. The primary component is Sodium Chloride; Sodium Lactate; Potassium Chloride; Calcium Chloride.

Product ID70529-027_0b603f42-c3fe-4a39-a2ac-02105bbc925b
NDC70529-027
Product TypeHuman Prescription Drug
Proprietary NameLacellate Solution - 1000
Generic NameSodium Chloride, Potassium Chloride, Sodium Lactate And Calcium Chloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-03-01
Marketing CategoryNDA / NDA
Application NumberNDA016682
Labeler NameIT3 Medical LLC
Substance NameSODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE
Active Ingredient Strength600 mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharm ClassesPotassium Compounds [CS],Potassium Salt [EPC],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]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70529-027-01

1 BAG in 1 PACKAGE (70529-027-01) > 1000 mL in 1 BAG
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70529-027-01 [70529002701]

Lacellate Solution - 1000 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM CHLORIDE600 mg/100mL

OpenFDA Data

SPL SET ID:91ae5b40-9b59-4231-8ab3-69502245d918
Manufacturer
UNII

Pharmacological Class

  • Potassium Compounds [CS]
  • Potassium Salt [EPC]
  • 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]

NDC Crossover Matching brand name "Lacellate Solution - 1000" or generic name "Sodium Chloride, Potassium Chloride, Sodium Lactate And Calcium Chloride"

NDCBrand NameGeneric Name
70529-027Lacellate Solution - 1000Sodium chloride, potassium chloride, sodium lactate and calcium chloride
70529-025Lacellate Solution - 250Sodium chloride, potassium chloride, sodium lactate and calcium chloride
70529-026Lacellate Solution - 500Sodium chloride, potassium chloride, sodium lactate and calcium chloride
0338-0117Lactated RingersSodium chloride, potassium chloride, sodium lactate and calcium chloride

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