Home NDC 14537-408-50 Isoplate
Product NDC 14537-408
Requested package NDC 14537-408-50
11-digit product format 145370408
Labeler code 14537
Product ID 14537-408_18d184d6-1606-4e5c-a25f-6a4acf283358
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE, MONOBASIC
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Terumo BCT Ltd.
Application BN090067
Marketing category NDA
Marketing start 2013-03-05
Marketing end 0000-00-00
Substance SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; POTASSIUM PHOSPHATE, MONOBASIC
Active strength 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MAGNESIUM CHLORIDE ACTIVE INGREDIENT 02F3473H9O ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5 POTASSIUM CHLORIDE ACTIVE INGREDIENT 660YQ98I10 ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5 POTASSIUM PHOSPHATE, MONOBASIC ACTIVE INGREDIENT 4J9FJ0HL51 ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5 SODIUM ACETATE ACTIVE INGREDIENT 4550K0SC9B ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5 SODIUM CHLORIDE ACTIVE INGREDIENT 451W47IQ8X ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5 SODIUM GLUCONATE ACTIVE INGREDIENT R6Q3791S76 ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5 SODIUM PHOSPHATE, DIBASIC ACTIVE INGREDIENT GR686LBA74 ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5 CHLORIDE ION ACTIVE MOIETY Q32ZN48698 ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5 POTASSIUM CATION ACTIVE MOIETY 295O53K152 ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14537-408 ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] 7 Legacy NDC 20250125_37932532-4fbf-4485-abe6-d2c9f9fc3b80.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 14537-408-50 14537040850 18 CONTAINER in 1 CASE (14537-408-50) > 500 mL in 1 CONTAINER 18 container 2013-03-05 0000-00-00 No No Current