ANDA 211087Abbreviated New Drug Application (ANDA) – generic drug
Approved September 9, 2020
Therapeutic equivalence (TE) code
APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers
6 labelers list this drug on DailyMed
Recalls
October 29, 2025: Class I recall: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
October 29, 2025: Class I recall: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
February 13, 2025: Class I recall: Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
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February 13, 2025: Class I recall: Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Packages (NDC)
Package
10 meq/100 mL – 100 ml in 1 bag / 50 in 1 carton
NDC 65219-012-00
10 meq/50 mL – 50 ml in 1 bag / 60 in 1 carton
NDC 65219-004-00
20 meq/100 mL – 100 ml in 1 bag / 50 in 1 carton
NDC 65219-006-00
20 meq/50 mL – 50 ml in 1 bag / 60 in 1 carton
NDC 65219-008-50
40 meq/100 mL – 100 ml in 1 bag / 50 in 1 carton
NDC 65219-010-00
Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.