Ketamine Injectable Solution

Brand(s)
Ketalar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Inc. (2015-10-06)
Oldest Current Product
1996-06-27
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTABLE SOLUTION\KETAMINE
FDAOB
INJECTION\INJECTION\KETAMINE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION, CONCENTRATE\KETAMINE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION, SOLUTION\KETAMINE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\KETAMINE HYDROCHLORIDE
INTRAVENOUS\INJECTION\KETAMINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION, CONCENTRATE\KETAMINE
INTRAMUSCULAR\INJECTION, SOLUTION\KETAMINE
INTRAMUSCULAR\INJECTION\KETAMINE
INTRAVENOUS\INJECTION\KETAMINE

product(s) by strength(s)

ketamine 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230113KetalarNDAPar Pharmaceutical Inc.2007-10-01KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA01681214e8f864-8b8a-4e7e-8439-e510d3107063

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230137NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2012-06-01KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA01681214b54219-f5fd-42fa-8784-719f9785497f
2674570181ANDAMylan Institutional Llc2013-06-04KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA076092505dc937-694d-4a3a-befa-aae20071b4c7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840037KetalarNDAGeneral Injecatables & Vaccines, Inc2012-10-17KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION420230113NDA0168129f675d38-d02f-455c-bc99-bac5924f5054

ketamine 100 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230115KetalarNDAPar Pharmaceutical Inc.2007-10-01KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA01681214e8f864-8b8a-4e7e-8439-e510d3107063

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092051ANDAHospira, Inc.1996-06-27KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION, CONCENTRATEANDA074549bb912318-2e22-4469-b0a2-774803ee1bb8
2420230139NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2012-06-01KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA01681214b54219-f5fd-42fa-8784-719f9785497f
3674570108ANDAMylan Institutional Llc2013-06-04KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA076092505dc937-694d-4a3a-befa-aae20071b4c7

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840040ANDAGeneral Injecatables & Vaccines, Inc2012-10-16KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION, CONCENTRATE004092051ANDA0745496faea7c1-7f67-4181-9e74-54175e315612
2617860348NDA AUTHORIZED GENERICRemedyrepack Inc.2015-06-18KETAMINE HYDROCHLORIDEINTRAVENOUSINJECTION420230139NDA01681291477b10-ca4a-4e8f-8b35-cd26a9f306e0

ketamine 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230114KetalarNDAPar Pharmaceutical Inc.2007-10-01KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA01681214e8f864-8b8a-4e7e-8439-e510d3107063

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092053ANDAHospira, Inc.1996-06-27KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION, CONCENTRATEANDA074549bb912318-2e22-4469-b0a2-774803ee1bb8
2420230138NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2012-06-01KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA01681214b54219-f5fd-42fa-8784-719f9785497f
3674570001ANDAMylan Institutional Llc2013-06-04KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA076092505dc937-694d-4a3a-befa-aae20071b4c7

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840038ANDAGeneral Injecatables & Vaccines, Inc2012-10-11KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION, CONCENTRATE004092053ANDA074549a6efa428-c61c-4b1b-9462-a17d9fe8a7ba
2548684399ANDAPhysicians Total Care, Inc.2002-03-12KETAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION, CONCENTRATE004092053ANDA07454994e75168-b271-4f7e-96d5-716eb9c32dfa

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA074524KETAMINE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL1996-03-22ANDA074524_001, ANDA074524_002
2ANDA074549KETAMINE HYDROCHLORIDEHOSPIRA INC1996-06-27ANDA074549_001, ANDA074549_002
3ANDA076092KETAMINE HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2001-12-28ANDA076092_001, ANDA076092_002, ANDA076092_003
4NDA016812KETALARPAR STERILE PRODUCTS LLCNDA016812_001, NDA016812_002, NDA016812_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074524_001RXKETAMINE HYDROCHLORIDE (EQ 50MG BASE/ML)INJECTIONFalseAP1996-03-22KETAMINE HYDROCHLORIDE
2ANDA074524_002RXKETAMINE HYDROCHLORIDE (EQ 100MG BASE/ML)INJECTIONFalseAP1996-03-22KETAMINE HYDROCHLORIDE
3ANDA074549_001RXKETAMINE HYDROCHLORIDE (EQ 50MG BASE/ML)INJECTIONFalseAP1996-06-27KETAMINE HYDROCHLORIDE
4ANDA074549_002RXKETAMINE HYDROCHLORIDE (EQ 100MG BASE/ML)INJECTIONFalseAP1996-06-27KETAMINE HYDROCHLORIDE
5ANDA076092_001RXKETAMINE HYDROCHLORIDE (EQ 10MG BASE/ML)INJECTIONFalseAP2008-09-30KETAMINE HYDROCHLORIDE
6ANDA076092_002RXKETAMINE HYDROCHLORIDE (EQ 50MG BASE/ML)INJECTIONFalseAP2001-12-28KETAMINE HYDROCHLORIDE
7ANDA076092_003RXKETAMINE HYDROCHLORIDE (EQ 100MG BASE/ML)INJECTIONFalseAP2002-10-25KETAMINE HYDROCHLORIDE
8NDA016812_001RXKETAMINE HYDROCHLORIDE (EQ 10MG BASE/ML)INJECTIONTrueAPKETALAR
9NDA016812_002RXKETAMINE HYDROCHLORIDE (EQ 50MG BASE/ML)INJECTIONTrueAPKETALAR
10NDA016812_003RXKETAMINE HYDROCHLORIDE (EQ 100MG BASE/ML)INJECTIONTrueAPKETALAR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
114b54219-f5fd-42fa-8784-719f9785497f (view SPL)Ketamine Hydrochloride Injection, USPprescriptionHuman PrescriptionPar Pharmaceutical Inc.2013-04-042420230137, 420230138, 420230139
214e8f864-8b8a-4e7e-8439-e510d3107063 (view SPL)Ketalar (ketamine hydrochloride) injectionprescriptionHuman PrescriptionPar Pharmaceutical Inc.2015-10-066420230113, 420230114, 420230115
3505dc937-694d-4a3a-befa-aae20071b4c7 (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2012-10-236674570001, 674570108, 674570181
46faea7c1-7f67-4181-9e74-54175e315612 (view SPL)Ketamine Hydrochloride Injection, USPRx onlyCIIIprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Increlabel2012-10-161525840040
591477b10-ca4a-4e8f-8b35-cd26a9f306e0 (view SPL)Ketamine Hydrochloride Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-06-181617860348
694e75168-b271-4f7e-96d5-716eb9c32dfa (view SPL)KetamineHydrochlorideInjection, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-04-231548684399
79f675d38-d02f-455c-bc99-bac5924f5054 (view SPL)Ketalar(Ketamine Hydrochloride Injection, USP)CIIIprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Increlabel2012-10-171525840037
8a6efa428-c61c-4b1b-9462-a17d9fe8a7ba (view SPL)Ketamine Hydrochloride Injection, USP Rx onlyCIIIprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-10-111525840038
9bb912318-2e22-4469-b0a2-774803ee1bb8 (view SPL)KetamineHydrochlorideprescriptionHuman PrescriptionHospira, Inc.2013-05-233004092051, 004092053

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