Sodium Chloride Irrigation Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2014-07-28)
Oldest Current Product
1974-04-08
License(s)
NDA
RxNORM
IRRIGATION SOLUTION\SODIUM CHLORIDE
FDAOB
IRRIGATION\SOLUTION, FOR SLUSH\SODIUM CHLORIDE
IRRIGATION\SOLUTION\SODIUM CHLORIDE
SPL Active
IRRIGATION\IRRIGANT\SODIUM CHLORIDE
IRRIGATION\SOLUTION\SODIUM CHLORIDE
SPL Moiety
IRRIGATION\IRRIGANT\CHLORIDE ION
IRRIGATION\IRRIGANT\SODIUM CATION
IRRIGATION\SOLUTION\CHLORIDE ION

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004097975NDAHospira, Inc.1980-08-052009-12-01SODIUM CHLORIDEIRRIGATIONIRRIGANTNDA01838087875438-569d-4bdb-3bba-4599f8c93365

sodium chloride 0.154 meq/ml irrigation solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002647388NDAB. Braun Medical Inc.2013-04-19SODIUM CHLORIDEIRRIGATIONSOLUTIONNDA0167335bd9b176-0402-4a3f-a6b4-c3f393fc092a
2003380047NDABaxter Healthcare Corporation1980-05-30SODIUM CHLORIDEIRRIGATIONIRRIGANTNDA01786705dee566-7b82-4216-8a6b-765d2b4d9dc7, 886f889b-f3cf-4197-b307-6cfa88c89436
3003380048NDABaxter Healthcare Corporation1974-12-31SODIUM CHLORIDEIRRIGATIONIRRIGANTNDA017427b3b4b176-41f0-4ca8-90d4-3fba5707564a
4004096138NDAHospira, Inc.1974-04-08SODIUM CHLORIDEIRRIGATIONIRRIGANTNDA01751487875438-569d-4bdb-3bba-4599f8c93365
5004097138NDAHospira, Inc.1974-04-08SODIUM CHLORIDEIRRIGATIONIRRIGANTNDA01751487875438-569d-4bdb-3bba-4599f8c93365

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551545177NDACardinal Health2009-09-14SODIUM CHLORIDEIRRIGATIONIRRIGANT002642201NDA016733f8cfc907-2b93-4f24-bf79-e2c11a72b83b
2617860217NDARemedyrepack Inc.2015-03-11SODIUM CHLORIDEIRRIGATIONIRRIGANT002642201NDA01673328d4f254-03d0-4362-a496-b7dd308c8d48

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1NDA016733SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERB BRAUN MEDICAL INCNDA016733_001
2NDA017427SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBAXTER HEALTHCARE CORPNDA017427_001
3NDA017514SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHOSPIRA INCNDA017514_001
4NDA017670SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERTrueHOSPIRA WORLDWIDE, INCNDA017670_001
5NDA017864SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERTrueBAXTER HEALTHCARE CORPNDA017864_001
6NDA017867SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBAXTER HEALTHCARE CORPNDA017867_001
7NDA018247SODIUM CHLORIDE IN PLASTIC CONTAINERTrueMILES LABORATORIES INCNDA018247_001
8NDA018314SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHOSPIRA INCNDA018314_001
9NDA018380SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERTrueHOSPIRA WORLDWIDE, INCNDA018380_001
10NDA018497SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERTrueBAXTER HEALTHCARE CORP1982-02-19NDA018497_001
11NDA019319SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINERBAXTER HEALTHCARE CORP1985-05-17NDA019319_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1NDA016733_001RXSODIUM CHLORIDE (900MG/100ML)IRRIGATIONSOLUTIONFalseATSODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
2NDA017427_001RXSODIUM CHLORIDE (900MG/100ML)IRRIGATIONSOLUTIONFalseATSODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
3NDA017514_001RXSODIUM CHLORIDE (900MG/100ML)IRRIGATIONSOLUTIONFalseATSODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
4NDA017670_001discontinuedSODIUM CHLORIDE (450MG/100ML)IRRIGATIONSOLUTIONFalseSODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
5NDA017864_001discontinuedSODIUM CHLORIDE (450MG/100ML)IRRIGATIONSOLUTIONFalseSODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
6NDA017867_001RXSODIUM CHLORIDE (900MG/100ML)IRRIGATIONSOLUTIONFalseATSODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
7NDA018247_001discontinuedSODIUM CHLORIDE (900MG/100ML)IRRIGATIONSOLUTIONFalseSODIUM CHLORIDE IN PLASTIC CONTAINER
8NDA018314_001RXSODIUM CHLORIDE (900MG/100ML)IRRIGATIONSOLUTIONFalseATSODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
9NDA018380_001discontinuedSODIUM CHLORIDE (450MG/100ML)IRRIGATIONSOLUTIONFalseSODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
10NDA018497_001discontinuedSODIUM CHLORIDE (450MG/100ML)IRRIGATIONSOLUTIONFalse1982-02-19SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
11NDA019319_002RXSODIUM CHLORIDE (900MG/100ML)IRRIGATIONSOLUTION, FOR SLUSHFalse1985-05-17SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
105dee566-7b82-4216-8a6b-765d2b4d9dc7 (view SPL)0.9% Sodium Chloride Irrigation, USPprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-07-254003380047
20d59a04a-32e6-485b-b638-a1e6c09e9642 (view SPL)0.9% Sodium ChlorideIrrigation USPprescriptionHuman PrescriptionB. Braun Medical Inc.2011-08-155002642201
328d4f254-03d0-4362-a496-b7dd308c8d48 (view SPL)0.9% Sodium ChlorideIrrigation USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-03-111617860217
42a96096d-43cc-49b7-af53-b53c17f41001 (view SPL)0.9% Sodium Chloride Processing Solution in Flexible Plastic Container Not for injectionprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-07-253003380050
55bd9b176-0402-4a3f-a6b4-c3f393fc092a (view SPL)0.9% Sodium Chloride Irrigation USPprescriptionHuman PrescriptionB. Braun Medical Inc.LABEL, MANUFACTURE, PACK2014-07-237002647388
67c72520e-de3c-493d-8aea-11933376d968 (view SPL)0.9% Sodium Chloride Irrigation, USP Baxter Sterile Container SystemprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2012-07-013003380051
787875438-569d-4bdb-3bba-4599f8c93365 (view SPL)0.45% SODIUM CHLORIDE IRRIGATION, USP 0.9% SODIUM CHLORIDE IRRIGATION, USPprescriptionHuman PrescriptionHospira, Inc.2013-09-1014004096138, 004097138, 004097975, 004097972
8886f889b-f3cf-4197-b307-6cfa88c89436 (view SPL)prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-07-284003380047
9b3b4b176-41f0-4ca8-90d4-3fba5707564a (view SPL)prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-02-212003380048
10d391d6a2-a616-4e89-f685-0b79bcb36d84 (view SPL)0.9% Sodium Chloride Irrigation, USPprescriptionHuman PrescriptionHospira, Inc.2014-03-2514004097972
11f8cfc907-2b93-4f24-bf79-e2c11a72b83b (view SPL)0.9% Sodium Chloride Irrigation USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-06-101551545177

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