NDC 70529-025

Lacellate Solution - 250

Sodium Chloride, Potassium Chloride, Sodium Lactate And Calcium Chloride

Lacellate Solution - 250 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 ID: 70529-025_75064e8d-c3bb-44cc-9e3c-95d1847ad37d
• NDC: 70529-025
• Product Type: Human Prescription Drug
• Proprietary Name: Lacellate Solution - 250
• Generic Name: Sodium Chloride, Potassium Chloride, Sodium Lactate And Calcium Chloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA016682
• Labeler Name: IT3 Medical LLC
• Substance Name: SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE
• Active Ingredient Strength: 600 mg/100mL; mg/100mL; mg/100mL; mg/100mL
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70529-025-01

1 BAG in 1 PACKAGE (70529-025-01) > 250 mL in 1 BAG

• Marketing Start Date: 2017-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70529-025-01 [70529002501]

Lacellate Solution - 250 INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA016682
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-03-01

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM CHLORIDE	600 mg/100mL

OpenFDA Data

• SPL SET ID: 6fbfe1f7-3db1-4c9f-aafb-d336a563c9c2
• Manufacturer:
  • IT3 Medical LLC
• UNII:
  • TU7HW0W0QT
  • M4I0D6VV5M
  • 451W47IQ8X
  • 660YQ98I10

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 - 250" or generic name "Sodium Chloride, Potassium Chloride, Sodium Lactate And Calcium Chloride"

NDC	Brand Name	Generic Name
70529-025	Lacellate Solution - 250	Sodium chloride, potassium chloride, sodium lactate and calcium chloride
70529-027	Lacellate Solution - 1000	Sodium chloride, potassium chloride, sodium lactate and calcium chloride
70529-026	Lacellate Solution - 500	Sodium chloride, potassium chloride, sodium lactate and calcium chloride
0338-0117	Lactated Ringers	Sodium chloride, potassium chloride, sodium lactate and calcium chloride