Sodium Acetate Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
American Regent, Inc. (2014-09-04)
Oldest Current Product
1990-09-30
License(s)
NDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\SODIUM ACETATE
FDAOB
INJECTION\INJECTION\SODIUM ACETATE ANHYDROUS\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\SODIUM ACETATE
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\SODIUM ACETATE ANHYDROUS
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\ACETATE ION
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\SODIUM CATION

product(s) by strength(s)

sodium acetate 2 meq/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004097299NDAHospira, Inc.1983-05-04, 2014-03-05SODIUM ACETATE ANHYDROUSINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA018893c91ede49-c7cc-47b7-0f93-e6841dd5916a, ce9a7469-c4ba-4f60-8f7a-47ef0974316e
2005172096UNAPPROVED DRUG OTHER MARKETING CATEGORYAmerican Regent, Inc.1990-09-30SODIUM ACETATE ANHYDROUSINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE67dfd0f0-b057-4737-9f68-0445b6b321d6

sodium acetate 4 meq/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1005175023UNAPPROVED DRUG OTHER MARKETING CATEGORYAmerican Regent, Inc.1990-09-30SODIUM ACETATE ANHYDROUSINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEb619ee23-26ca-48c8-be40-7911f575e43d
2633230032UNAPPROVED DRUG OTHER MARKETING CATEGORYApp Pharmaceuticals, Llc2000-09-01SODIUM ACETATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEd7fabf08-d4e0-4bb5-8416-2e8ffe27c04b

application(s)

#idtitleapplicantapprovedapproved drug
1NDA018893SODIUM ACETATE IN PLASTIC CONTAINERHOSPIRA INC1983-05-04NDA018893_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA018893_001RXSODIUM ACETATE ANHYDROUS (2MEQ/ML)INJECTIONTrue1983-05-04SODIUM ACETATE IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
167dfd0f0-b057-4737-9f68-0445b6b321d6 (view SPL)SODIUM ACETATE INJECTION, USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-12-145005172096
2abc41ed1-9512-4bea-9295-1a9ca134b6c2 (view SPL)SODIUM ACETATEprescriptionHuman PrescriptionHospira, Inc.2015-03-305004093299
3b619ee23-26ca-48c8-be40-7911f575e43d (view SPL)SODIUM ACETATE FOR INJECTION, USP CONCENTRATEprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE, STERILIZE2014-09-043005175023
4c3be2468-45e8-4ecc-a30b-e966743a563f (view SPL)SODIUMACETATERx onlyprescriptionHuman PrescriptionHospira, Inc.2015-03-302004093299
5c91ede49-c7cc-47b7-0f93-e6841dd5916a (view SPL)SODIUM ACETATEprescriptionHuman PrescriptionHospira, Inc.2014-07-1811004097299
6ce9a7469-c4ba-4f60-8f7a-47ef0974316e (view SPL)Sodium Acetate Injection USPprescriptionHuman PrescriptionHospira, Inc.2014-07-181004097299
7d7fabf08-d4e0-4bb5-8416-2e8ffe27c04b (view SPL)Sodium Acetate Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-07-271633230032

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