NDC 0990-7929

Lactated Ringers and Dextrose

Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate

Lactated Ringers and Dextrose is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Icu Medical Inc.. The primary component is Sodium Chloride; Sodium Lactate; Potassium Chloride; Calcium Chloride; Dextrose Monohydrate.

• Product ID: 0990-7929_4e45ab94-ad09-4cb2-9485-c91b6e7081d5
• NDC: 0990-7929
• Product Type: Human Prescription Drug
• Proprietary Name: Lactated Ringers and Dextrose
• Generic Name: Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-06-24
• Marketing Category: NDA / NDA
• Application Number: NDA017608
• Labeler Name: ICU Medical Inc.
• Substance Name: SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE
• Active Ingredient Strength: 600 mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL
• Pharm Classes: Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],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: 2022-12-31

Packaging

NDC 0990-7929-03

24 POUCH in 1 CASE (0990-7929-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

• Marketing Start Date: 2019-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0990-7929-09 [00990792909]

Lactated Ringers and Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017608
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-08-01

NDC 0990-7929-03 [00990792903]

Lactated Ringers and Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017608
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-08-01

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM CHLORIDE	600 mg/100mL

OpenFDA Data

• SPL SET ID: d310d170-5eeb-471b-af1a-0e845001d21d
• Manufacturer:
  • ICU Medical Inc.
• UNII:
  • TU7HW0W0QT
  • M4I0D6VV5M
  • LX22YL083G
  • 451W47IQ8X
  • 660YQ98I10
• RxNorm Concept Unique ID - RxCUI:
  • 847630
  • 847627

Pharmacological Class

• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Potassium Compounds [CS]
• Potassium Salt [EPC]
• Blood Coagulation Factor [EPC]
• Increased Coagulation Factor Activity [PE]
• Calcium [CS]
• Cations
• Divalent [CS]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• 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 "Lactated Ringers and Dextrose" or generic name "Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate"

NDC	Brand Name	Generic Name
0338-0125	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATE
0409-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE
0990-7929	Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE
51662-1229	LACTATED RINGERS AND DEXTROSE	SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE, DEXTROSE
51662-1521	LACTATED RINGERS AND DEXTROSE	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE