Details for New Drug Application (NDA): 212348
✉ Email this page to a colleague
The generic ingredient in POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
Summary for 212348
Tradename: | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER |
Applicant: | Fresenius Kabi Usa |
Ingredient: | dextrose; potassium chloride; sodium chloride |
Patents: | 0 |
Pharmacology for NDA: 212348
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 212348
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 212348 | ANDA | Fresenius Kabi USA, LLC | 65219-151 | 65219-151-75 | 20 BAG in 1 CASE (65219-151-75) / 500 mL in 1 BAG (65219-151-00) |
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 212348 | ANDA | Fresenius Kabi USA, LLC | 65219-153 | 65219-153-10 | 10 BAG in 1 CASE (65219-153-10) / 1000 mL in 1 BAG (65219-153-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;149MG/100ML;225MG/100ML | ||||
Approval Date: | Jul 30, 2021 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;149MG/100ML;225MG/100ML | ||||
Approval Date: | Jul 30, 2021 | TE: | AP | RLD: | No |
Complete Access Available with Subscription