Potassium Chloride / Sodium Chloride Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2014-07-24)
Oldest Current Product
1979-02-02
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\POTASSIUM CHLORIDE:SODIUM CHLORIDE
FDAOB
INJECTION\INJECTION\POTASSIUM CHLORIDE: SODIUM CHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\POTASSIUM CHLORIDE: SODIUM CHLORIDE
INTRAVENOUS\SOLUTION\POTASSIUM CHLORIDE: SODIUM CHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\CHLORIDE ION
INTRAVENOUS\INJECTION, SOLUTION\POTASSIUM CATION: SODIUM CATION
INTRAVENOUS\SOLUTION\POTASSIUM CATION: SODIUM CATION

product(s) by strength(s)

potassium chloride 0.02 meq/ml / sodium chloride 0.0769 meq/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003380704NDABaxter Healthcare Corporation1979-02-02POTASSIUM CHLORIDE, SODIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA017648becc7410-0a25-49f5-b0c3-240078479dc8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004099257ANDAHospira, Inc.2008-09-10POTASSIUM CHLORIDE, SODIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA0784463a3343e4-b480-4454-e28b-9f3cba932948

potassium chloride 0.02 meq/ml / sodium chloride 0.154 meq/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002647865NDAB. Braun Medical Inc.1989-09-29POTASSIUM CHLORIDE, SODIUM CHLORIDEINTRAVENOUSSOLUTIONNDA019708ecc38772-246a-46c4-b42a-b9b81124f27f
2004097115NDAHospira, Inc.1988-10-17POTASSIUM CHLORIDE, SODIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA01968678e70270-3864-423e-f89b-656822fa35df

potassium chloride 0.04 meq/ml / sodium chloride 0.154 meq/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003380695NDABaxter Healthcare Corporation1979-02-02POTASSIUM CHLORIDE, SODIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA017648becc7410-0a25-49f5-b0c3-240078479dc8

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA078446POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERHOSPIRA INC2008-09-10ANDA078446_001
2NDA017648POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBAXTER HEALTHCARE CORPNDA017648_001, NDA017648_002, NDA017648_003, NDA017648_004, NDA017648_005
3NDA018722SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINERTrueB BRAUN MEDICAL INC1982-11-09NDA018722_001, NDA018722_002, NDA018722_003, NDA018722_004
4NDA019686POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHOSPIRA INC1988-10-17NDA019686_001, NDA019686_002
5NDA019708POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERB BRAUN MEDICAL INC1989-09-29NDA019708_001, NDA019708_002, NDA019708_003, NDA019708_004, NDA019708_005, NDA019708_006

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA078446_001RXSODIUM CHLORIDE (450MG/100ML), POTASSIUM CHLORIDE (149MG/100ML)INJECTIONFalseAP2008-09-10POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
2NDA017648_001RXPOTASSIUM CHLORIDE (150MG/100ML), SODIUM CHLORIDE (900MG/100ML)INJECTIONFalseAPPOTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
3NDA017648_002RXPOTASSIUM CHLORIDE (300MG/100ML), SODIUM CHLORIDE (900MG/100ML)INJECTIONFalseAPPOTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
4NDA017648_003RXPOTASSIUM CHLORIDE (224MG/100ML), SODIUM CHLORIDE (900MG/100ML)INJECTIONFalsePOTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
5NDA017648_004discontinuedSODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (75MG/100ML)INJECTIONFalsePOTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
6NDA017648_005RXSODIUM CHLORIDE (450MG/100ML), POTASSIUM CHLORIDE (150MG/100ML)INJECTIONTrueAP2002-11-26POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
7NDA018722_001discontinuedSODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (75MG/100ML)INJECTIONFalse1982-11-09SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
8NDA018722_002discontinuedPOTASSIUM CHLORIDE (150MG/100ML), SODIUM CHLORIDE (900MG/100ML)INJECTIONFalse1982-11-09SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
9NDA018722_003discontinuedSODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (220MG/100ML)INJECTIONFalse1982-11-09SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
10NDA018722_004discontinuedSODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (300MG/100ML)INJECTIONFalse1982-11-09SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
11NDA019686_001RXPOTASSIUM CHLORIDE (149MG/100ML), SODIUM CHLORIDE (900MG/100ML)INJECTIONFalseAP1988-10-17POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
12NDA019686_002RXSODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (298MG/100ML)INJECTIONFalseAP1988-10-17POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
13NDA019708_001discontinuedSODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (37MG/100ML)INJECTIONFalse1989-09-29POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
14NDA019708_002discontinuedPOTASSIUM CHLORIDE (75MG/100ML), SODIUM CHLORIDE (900MG/100ML)INJECTIONFalse1989-09-29POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
15NDA019708_003discontinuedSODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (110MG/100ML)INJECTIONFalse1989-09-29POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
16NDA019708_004RXSODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (150MG/100ML)INJECTIONFalseAP1989-09-29POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
17NDA019708_005discontinuedSODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (220MG/100ML)INJECTIONFalse1989-09-29POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
18NDA019708_006discontinuedPOTASSIUM CHLORIDE (300MG/100ML), SODIUM CHLORIDE (900MG/100ML)INJECTIONFalse1989-09-29POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13a3343e4-b480-4454-e28b-9f3cba932948 (view SPL)Potassium Chloride in Sodium Chloride Injection, USPprescriptionHuman PrescriptionHospira, Inc.2013-12-0212004099257
278e70270-3864-423e-f89b-656822fa35df (view SPL)INTRAVENOUS SOLUTIONS with POTASSIUM CHLORIDEprescriptionHuman PrescriptionHospira, Inc.2012-08-1312004097115, 004097116
3becc7410-0a25-49f5-b0c3-240078479dc8 (view SPL)Potassium Chloride in Sodium Chloride Injection, USP in Plastic Container VIAFLEX Plus ContainerprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-07-245003380695, 003380704, 003380691
4ecc38772-246a-46c4-b42a-b9b81124f27f (view SPL)Potassium Chloride in 0.9% Sodium Chloride InjectionsprescriptionHuman PrescriptionB. Braun Medical Inc.2011-08-177002647865, 002647885

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