Home NDC 65219-153 Potassium Chloride in Dextrose and Sodium Chloride
Product NDC 65219-153
11-digit product format 652190153
Labeler code 65219
Product ID 65219-153_6320e059-cc2f-48b8-8ef5-c0080c35eaca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA212348
Marketing category ANDA
Marketing start 2022-09-02
Substance DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Active strength 50; 1.49; 2.25 g/1000mL; g/1000mL; g/1000mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Potassium Chloride in Dextrose and Sodium Chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROSE MONOHYDRATE 50 g/1000mL SODIUM CHLORIDE 1.49 g/1000mL POTASSIUM CHLORIDE 2.25 g/1000mL
Harmonized Identifiers# Field, Values table Field Values Unii LX22YL083G, 451W47IQ8X, 660YQ98I10 Rxcui 1863973, 1863975
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65219-153-02 Potassium Chloride in Dextrose and Sodium Chloride 1000 mL in 1 BAG INJECTION, SOLUTION 1000 5 65219-153-10 Potassium Chloride in Dextrose and Sodium Chloride 10 in 1 CASE INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-153 POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240625_f0cc6713-4d47-49be-8116-901c99002b6b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65219-153-02 65219015302 1000 mL in 1 BAG 1000 ml Historical 65219-153-10 65219015310 10 BAG in 1 CASE (65219-153-10) / 1000 mL in 1 BAG (65219-153-02) 10 bag 2022-09-02 0000-00-00 No No Current