Details for New Drug Application (NDA): 213523
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NDA 213523 describes POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, which is a drug marketed by Fresenius Kabi Usa, Baxter Hlthcare, and Icu Medical Inc, and is included in three NDAs. It is available from one supplier. Additional details are available on the POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% profile page.
The generic ingredient in POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% 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.
The generic ingredient in POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% 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 213523
| Tradename: | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | dextrose; potassium chloride; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 213523
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 213523
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 213523 | ANDA | Fresenius Kabi USA, LLC | 65219-142 | 65219-142-10 | 10 BAG in 1 CASE (65219-142-10) / 1000 mL in 1 BAG (65219-142-02) |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 213523 | ANDA | Fresenius Kabi USA, LLC | 65219-144 | 65219-144-10 | 10 BAG in 1 CASE (65219-144-10) / 1000 mL in 1 BAG (65219-144-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;74.5MG/100ML;450MG/100ML | ||||
| Approval Date: | Mar 9, 2021 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;149MG/100ML;450MG/100ML | ||||
| Approval Date: | Mar 9, 2021 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;224MG/100ML;450MG/100ML | ||||
| Approval Date: | Mar 9, 2021 | TE: | AP | RLD: | No | ||||
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