Furosemide Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
American Regent, Inc. (2014-02-24)
Oldest Current Product
1982-05-28
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTION\FUROSEMIDE
FDAOB
INJECTION\INJECTION\FUROSEMIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\FUROSEMIDE
INTRAMUSCULAR\INJECTION\FUROSEMIDE
INTRAVENOUS\INJECTION, SOLUTION\FUROSEMIDE
INTRAVENOUS\INJECTION\FUROSEMIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\FUROSEMIDE
INTRAMUSCULAR\INJECTION\FUROSEMIDE
INTRAVENOUS\INJECTION, SOLUTION\FUROSEMIDE
INTRAVENOUS\INJECTION\FUROSEMIDE

product(s) by strength(s)

furosemide 10 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096102NDAHospira, Inc.1982-05-28FUROSEMIDEINTRAMUSCULARINJECTION, SOLUTIONNDA01866739fd32f2-6bb7-4a65-d298-e48d26bc80c7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550473ANDAHeritage Pharmaceuticals Inc.2014-09-02FUROSEMIDEINTRAVENOUSINJECTION, SOLUTIONANDA2034281b9117d5-0dd9-4577-a1fd-bb0aaf7e68ec
2231550521ANDAHeritage Pharmaceuticals Inc.2015-06-26FUROSEMIDEINTRAVENOUSINJECTION, SOLUTIONANDA203428d10cc602-6bb6-4fbe-989d-8307d37eb252

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840102NDAGeneral Injecatables & Vaccines, Inc2010-08-01FUROSEMIDEINTRAMUSCULARINJECTION, SOLUTION004096102NDA018667869c9eeb-baae-4189-aa5e-0b4e1ee172d2

4 ml furosemide 10 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005175704NDAAmerican Regent, Inc.1990-09-30FUROSEMIDEINTRAVENOUSINJECTIONNDA0185792d6a6ff9-3f12-4a6e-bba3-3f85fd54ffac

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1360000064ANDAClaris Lifesciences Inc.2014-02-06FUROSEMIDEINTRAVENOUSINJECTION, SOLUTIONANDA202747c71371a7-75c5-45b8-b762-8d782d4c71bc
2360000283ANDAClaris Lifesciences Inc.2014-02-06FUROSEMIDEINTRAVENOUSINJECTION, SOLUTIONANDA202747c71371a7-75c5-45b8-b762-8d782d4c71bc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840704NDAGeneral Injecatables & Vaccines, Inc2010-09-01FUROSEMIDEINTRAMUSCULARINJECTION, SOLUTION005175704NDA018579d71487aa-c181-4549-a16a-61551490dec0
2551542365NDA AUTHORIZED GENERICCardinal Health2010-07-13FUROSEMIDEINTRAMUSCULARINJECTION, SOLUTION004096102NDA01866771b48f4d-9936-448c-9e3a-33f1182e1039
3551544727NDA AUTHORIZED GENERICCardinal Health2010-07-13FUROSEMIDEINTRAMUSCULARINJECTION, SOLUTION004096102NDA0186678610f683-1459-479f-9ced-5c766e134542
4551545705NDACardinal Health1990-09-30FUROSEMIDEINTRAVENOUSINJECTION005175704NDA018579e1badec1-77bd-481a-a93c-3150eaeee814
5637390464NDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2010-02-01FUROSEMIDEINTRAMUSCULARINJECTION005175702NDA01857919152554-70b0-42fb-a3d5-65ceb00e60e3

10 ml furosemide 10 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005175710NDAAmerican Regent, Inc.1990-09-30FUROSEMIDEINTRAVENOUSINJECTIONNDA0185792d6a6ff9-3f12-4a6e-bba3-3f85fd54ffac

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1360000065ANDAClaris Lifesciences Inc.2014-02-06FUROSEMIDEINTRAVENOUSINJECTION, SOLUTIONANDA202747c71371a7-75c5-45b8-b762-8d782d4c71bc
2360000284ANDAClaris Lifesciences Inc.2014-02-06FUROSEMIDEINTRAVENOUSINJECTION, SOLUTIONANDA202747c71371a7-75c5-45b8-b762-8d782d4c71bc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682299NDAPhysicians Total Care, Inc.2005-09-29FUROSEMIDEINTRAVENOUSINJECTION005175710NDA01857927fbf6d5-2853-4f26-bf50-9eac8bb82785
2551542391NDA AUTHORIZED GENERICCardinal Health2010-07-13FUROSEMIDEINTRAMUSCULARINJECTION, SOLUTION004096102NDA0186672633c775-8a3e-44d4-8909-0f34dc59d405, 342a0b3b-3638-4c43-9ff6-1f8cfd6c5b6c
3551545704NDACardinal Health1990-09-30FUROSEMIDEINTRAVENOUSINJECTION005175710NDA018579e1badec1-77bd-481a-a93c-3150eaeee814
4617860213ANDARemedyrepack Inc.2015-03-07FUROSEMIDEINTRAVENOUSINJECTION, SOLUTION360000284ANDA202747bf2513c1-49f5-4f6a-a76d-1c6a9e6c5dfb

2 ml furosemide 10 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005175702NDAAmerican Regent, Inc.1990-09-30FUROSEMIDEINTRAVENOUSINJECTIONNDA0185792d6a6ff9-3f12-4a6e-bba3-3f85fd54ffac

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1360000063ANDAClaris Lifesciences Inc.2014-02-06FUROSEMIDEINTRAVENOUSINJECTION, SOLUTIONANDA202747c71371a7-75c5-45b8-b762-8d782d4c71bc
2360000282ANDAClaris Lifesciences Inc.2014-02-06FUROSEMIDEINTRAVENOUSINJECTION, SOLUTIONANDA202747c71371a7-75c5-45b8-b762-8d782d4c71bc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950721NDARebel Distributors Corp1983-11-30FUROSEMIDEINTRAMUSCULARINJECTION005175702NDA0185793ec788b9-b851-4022-a3ef-8ec72bc3d258
2525840702NDAGeneral Injecatables & Vaccines, Inc2010-08-01FUROSEMIDEINTRAMUSCULARINJECTION, SOLUTION005175702NDA0185796040a2ec-3385-44dd-9f8e-f87ad6474be7
3551542364NDA AUTHORIZED GENERICCardinal Health2010-07-13FUROSEMIDEINTRAMUSCULARINJECTION, SOLUTION004096102NDA0186678e0bac29-5a8b-4d4e-93b3-2e21eb3b0650
4551545701NDACardinal Health1990-09-30FUROSEMIDEINTRAVENOUSINJECTION005175702NDA018579e1badec1-77bd-481a-a93c-3150eaeee814

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070014FUROSEMIDETrueASTRAZENECA LP1985-09-09ANDA070014_001Furosemide Prefilled Syringe
2ANDA070017FUROSEMIDETrueORGANON USA INC1986-12-15ANDA070017_001Furosemide Prefilled Syringe
3ANDA070019FUROSEMIDETrueWATSON LABORATORIES INC1986-09-22ANDA070019_001Furosemide Prefilled Syringe
4ANDA070023FUROSEMIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1986-02-05ANDA070023_001Furosemide Prefilled Syringe
5ANDA070078FUROSEMIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1986-02-05ANDA070078_001Furosemide Prefilled Syringe
6ANDA070095FUROSEMIDETrueIGI LABORATORIES INC1985-09-09ANDA070095_001Furosemide Prefilled Syringe
7ANDA070096FUROSEMIDETrueIGI LABORATORIES INC1985-09-09ANDA070096_001Furosemide Prefilled Syringe
8ANDA070578FUROSEMIDETrueHOSPIRA INC1987-07-08ANDA070578_001Furosemide Prefilled Syringe
9ANDA070604FUROSEMIDETrueWATSON LABORATORIES INC1987-01-02ANDA070604_001Furosemide Prefilled Syringe
10ANDA071439FUROSEMIDETrueHIKMA MAPLE LTD1990-09-14ANDA071439_001Furosemide Prefilled Syringe
11ANDA072080FUROSEMIDETrueHOSPIRA INC1991-08-13ANDA072080_001Furosemide Prefilled Syringe
12ANDA074017FUROSEMIDETrueMARSAM PHARMACEUTICALS LLC1994-06-30ANDA074017_001Furosemide Prefilled Syringe
13ANDA074337FUROSEMIDETrueHOSPIRA INC1994-10-31ANDA074337_001Furosemide Prefilled Syringe
14ANDA075241FUROSEMIDEHOSPIRA INC1999-05-28ANDA075241_001Furosemide Prefilled Syringe
15ANDA077941FUROSEMIDEWOCKHARDT LTD2007-03-22ANDA077941_001Furosemide Prefilled Syringe
16ANDA202747FUROSEMIDECLARIS LIFESCIENCES LTD2014-01-27ANDA202747_001Furosemide Prefilled Syringe
17ANDA203428FUROSEMIDEEMCURE PHARMACEUTICALS LTD2014-08-26ANDA203428_001Furosemide Prefilled Syringe
18NDA016363LASIXTrueSANOFI AVENTIS US LLCNDA016363_001Furosemide Prefilled Syringe
19NDA018025FUROSEMIDETrueINTERNATIONAL MEDICATION SYSTEMNDA018025_001Furosemide Prefilled Syringe
20NDA018267FUROSEMIDETrueHIKMA MAPLE LTDNDA018267_001Furosemide Prefilled Syringe
21NDA018420FUROSEMIDETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1982-02-26NDA018420_001Furosemide Prefilled Syringe
22NDA018507FUROSEMIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1982-07-30NDA018507_001Furosemide Prefilled Syringe
23NDA018579FUROSEMIDELUITPOLD PHARMACEUTICALS INC1983-11-30NDA018579_001Furosemide Prefilled Syringe
24NDA018667FUROSEMIDEHOSPIRA INC1982-05-28NDA018667_001Furosemide Prefilled Syringe
25NDA018670FUROSEMIDETrueWYETH AYERST LABORATORIES1982-07-20NDA018670_001Furosemide Prefilled Syringe
26NDA018902FUROSEMIDEFRESENIUS KABI USA LLC1984-05-22NDA018902_001Furosemide Prefilled Syringe
27NDA019036FUROSEMIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1984-08-13NDA019036_001Furosemide Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070014_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1985-09-09FUROSEMIDE
2ANDA070017_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1986-12-15FUROSEMIDE
3ANDA070019_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1986-09-22FUROSEMIDE
4ANDA070023_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1986-02-05FUROSEMIDE
5ANDA070078_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1986-02-05FUROSEMIDE
6ANDA070095_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1985-09-09FUROSEMIDE
7ANDA070096_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1985-09-09FUROSEMIDE
8ANDA070578_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1987-07-08FUROSEMIDE
9ANDA070604_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1987-01-02FUROSEMIDE
10ANDA071439_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1990-09-14FUROSEMIDE
11ANDA072080_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1991-08-13FUROSEMIDE
12ANDA074017_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1994-06-30FUROSEMIDE
13ANDA074337_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1994-10-31FUROSEMIDE
14ANDA075241_001RXFUROSEMIDE (10MG/ML)INJECTIONFalseAP1999-05-28FUROSEMIDE
15ANDA077941_001RXFUROSEMIDE (10MG/ML)INJECTIONFalseAP2007-03-22FUROSEMIDE
16ANDA202747_001RXFUROSEMIDE (10MG/ML)INJECTIONFalseAP2014-01-27FUROSEMIDE
17ANDA203428_001RXFUROSEMIDE (10MG/ML)INJECTIONFalseAP2014-08-26FUROSEMIDE
18NDA016363_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalseLASIX
19NDA018025_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalseFUROSEMIDE
20NDA018267_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalseFUROSEMIDE
21NDA018420_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1982-02-26FUROSEMIDE
22NDA018507_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1982-07-30FUROSEMIDE
23NDA018579_001RXFUROSEMIDE (10MG/ML)INJECTIONTrueAP1983-11-30FUROSEMIDE
24NDA018667_001RXFUROSEMIDE (10MG/ML)INJECTIONFalseAP1982-05-28FUROSEMIDE
25NDA018670_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1982-07-20FUROSEMIDE
26NDA018902_001RXFUROSEMIDE (10MG/ML)INJECTIONFalseAP1984-05-22FUROSEMIDE
27NDA019036_001discontinuedFUROSEMIDE (10MG/ML)INJECTIONFalse1984-08-13FUROSEMIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
119152554-70b0-42fb-a3d5-65ceb00e60e3 (view SPL)FUROSEMIDEINJECTION, USP40 mg/mL(10 mg/mL)prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationMANUFACTURE, REPACK2010-01-111637390464
21b9117d5-0dd9-4577-a1fd-bb0aaf7e68ec (view SPL)Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-10-084231550473
32633c775-8a3e-44d4-8909-0f34dc59d405 (view SPL)FurosemideprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-151551542391
427fbf6d5-2853-4f26-bf50-9eac8bb82785 (view SPL)FUROSEMIDEINJECTION, USP10 mg/mLprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-03-011548682299
52d6a6ff9-3f12-4a6e-bba3-3f85fd54ffac (view SPL)FUROSEMIDEINJECTION, USP10 mg/mLprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE, STERILIZE2014-02-246005175702, 005175704, 005175710
6342a0b3b-3638-4c43-9ff6-1f8cfd6c5b6c (view SPL)FurosemideprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-221551542391
739fd32f2-6bb7-4a65-d298-e48d26bc80c7 (view SPL)FurosemideprescriptionHuman PrescriptionHospira, Inc.2013-10-1415004096102, 004091639, 004099631Furosemide Prefilled Syringe
83ec788b9-b851-4022-a3ef-8ec72bc3d258 (view SPL)FUROSEMIDEINJECTION, USP10 mg/mLprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-281216950721
96040a2ec-3385-44dd-9f8e-f87ad6474be7 (view SPL)Furosemide 10 mg/mL Injection, USP 2 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-241525840702
1071b48f4d-9936-448c-9e3a-33f1182e1039 (view SPL)FurosemideprescriptionHuman PrescriptionCardinal HealthREPACK2013-09-113551542365
118610f683-1459-479f-9ced-5c766e134542 (view SPL)FurosemideprescriptionHuman PrescriptionCardinal HealthREPACK2014-04-302551544727
12869c9eeb-baae-4189-aa5e-0b4e1ee172d2 (view SPL)Furosemide Injection, USP(10 mg/mL)Fliptop VialAnsyr Plastic SyringeRx onlyprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-07-125525840102
138e0bac29-5a8b-4d4e-93b3-2e21eb3b0650 (view SPL)FurosemideprescriptionHuman PrescriptionCardinal HealthREPACK2014-10-154551542364
14bf2513c1-49f5-4f6a-a76d-1c6a9e6c5dfb (view SPL)FUROSEMIDE INJECTION, USP 10 mg/mLprescriptionHuman PrescriptionRemedyrepack Inc.2015-03-071617860213
15c71371a7-75c5-45b8-b762-8d782d4c71bc (view SPL)FUROSEMIDE INJECTION, USP 10 mg/mLprescriptionHuman PrescriptionClaris Lifesciences Inc.2015-06-298360000063, 360000064, 360000065, 360000282, 360000283, 360000284
16c794c95a-654e-48fe-9596-201fc122ff75 (view SPL)FUROSEMIDE INJECTION USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-09-041633230280
17d10cc602-6bb6-4fbe-989d-8307d37eb252 (view SPL)Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-06-261231550521
18d71487aa-c181-4549-a16a-61551490dec0 (view SPL)Furosemide 10 mg/mL Injection, USP 4 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-09-081525840704
19e1badec1-77bd-481a-a93c-3150eaeee814 (view SPL)FUROSEMIDEINJECTION, USP10 mg/mLprescriptionHuman PrescriptionCardinal HealthREPACK2012-04-101551545701, 551545704, 551545705

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