Glucose / Potassium Chloride Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2015-03-07)
Oldest Current Product
1979-02-01
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\GLUCOSE:POTASSIUM CHLORIDE
FDAOB
INJECTION\INJECTION\DEXTROSE: POTASSIUM CHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\DEXTROSE MONOHYDRATE: POTASSIUM CHLORIDE
INTRAVENOUS\SOLUTION\DEXTROSE, UNSPECIFIED FORM: POTASSIUM CHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ANHYDROUS DEXTROSE: CHLORIDE ION
INTRAVENOUS\SOLUTION\DEXTROSE, UNSPECIFIED FORM: POTASSIUM CATION

product(s) by strength(s)

glucose 50 mg/ml / potassium chloride 0.02 meq/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002647625NDAB. Braun Medical Inc.1989-09-29DEXTROSE, UNSPECIFIED FORM, POTASSIUM CHLORIDEINTRAVENOUSSOLUTIONNDA019699e5bbb3e1-ab50-4ec7-a2b4-ce4091712e23
2003380683NDABaxter Healthcare Corporation1979-02-01DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA01763445de5402-5e61-4bbd-8bbc-5e3392c9920e

glucose 50 mg/ml / potassium chloride 0.03 meq/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004097996NDAHospira, Inc.1980-05-29DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA0183716888a502-6fe6-4e4d-7c9f-be6d37700d8a

glucose 50 mg/ml / potassium chloride 0.04 meq/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004097906NDAHospira, Inc.1980-05-29DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA0183716888a502-6fe6-4e4d-7c9f-be6d37700d8a

application(s)

#idtitleapplicantapprovedapproved drug
1NDA017634DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINERBAXTER HEALTHCARE CORPNDA017634_001, NDA017634_002, NDA017634_003, NDA017634_004
2NDA018371POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERHOSPIRA INCNDA018371_001, NDA018371_002, NDA018371_003
3NDA018744POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINERB BRAUN MEDICAL INC1982-11-09NDA018744_001, NDA018744_002, NDA018744_003, NDA018744_004
4NDA019699POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINERB BRAUN MEDICAL INC1989-09-29NDA019699_001, NDA019699_002, NDA019699_003, NDA019699_004, NDA019699_005, NDA019699_006

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1NDA017634_001RXDEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (150MG/100ML)INJECTIONFalseAPDEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
2NDA017634_002RXDEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (300MG/100ML)INJECTIONFalseAPDEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
3NDA017634_003RXDEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (224MG/100ML)INJECTIONFalseAPDEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
4NDA017634_004RXPOTASSIUM CHLORIDE (75MG/100ML), DEXTROSE (5GM/100ML)INJECTIONFalseAPDEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
5NDA018371_001RXPOTASSIUM CHLORIDE (149MG/100ML), DEXTROSE (5GM/100ML)INJECTIONFalsePOTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
6NDA018371_002RXPOTASSIUM CHLORIDE (298MG/100ML), DEXTROSE (5GM/100ML)INJECTIONFalsePOTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
7NDA018371_003RXPOTASSIUM CHLORIDE (224MG/100ML), DEXTROSE (5GM/100ML)INJECTIONFalseAPPOTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
8NDA018744_001RXPOTASSIUM CHLORIDE (75MG/100ML), DEXTROSE (5GM/100ML)INJECTIONFalseAP1982-11-09POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
9NDA018744_002RXDEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (150MG/100ML)INJECTIONFalseAP1982-11-09POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
10NDA018744_003discontinuedDEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (220MG/100ML)INJECTIONFalse1982-11-09POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
11NDA018744_004RXPOTASSIUM CHLORIDE (300MG/100ML), DEXTROSE (5GM/100ML)INJECTIONFalseAP1982-11-09POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
12NDA019699_001discontinuedPOTASSIUM CHLORIDE (37MG/100ML), DEXTROSE (5GM/100ML)INJECTIONFalse1989-09-29POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
13NDA019699_002discontinuedPOTASSIUM CHLORIDE (75MG/100ML), DEXTROSE (5GM/100ML)INJECTIONFalse1989-09-29POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
14NDA019699_003discontinuedDEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (110MG/100ML)INJECTIONFalse1989-09-29POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
15NDA019699_004RXPOTASSIUM CHLORIDE (150MG/100ML), DEXTROSE (5GM/100ML)INJECTIONFalseAP1989-09-29POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
16NDA019699_005discontinuedDEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (220MG/100ML)INJECTIONFalse1989-09-29POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
17NDA019699_006RXPOTASSIUM CHLORIDE (300MG/100ML), DEXTROSE (5GM/100ML)INJECTIONFalseAP1989-09-29POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
145de5402-5e61-4bbd-8bbc-5e3392c9920e (view SPL)Potassium Chloride in 5% Dextrose Injection, USP in Plastic Container VIAFLEX Plus ContainerprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-03-077003380683
26888a502-6fe6-4e4d-7c9f-be6d37700d8a (view SPL)POTASSIUM CHLORIDEin Dextrose Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-03-1312004097906, 004097996, 004097905
3e5bbb3e1-ab50-4ec7-a2b4-ce4091712e23 (view SPL)Potassium Chloride in 5% Dextrose Injections USPprescriptionHuman PrescriptionB. Braun Medical Inc.2011-07-118002647625, 002647628

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII