Nafcillin Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2015-04-03)
Oldest Current Product
1984-08-02
License(s)
NDA, ANDA
RxNORM
INJECTION\NAFCILLIN
FDAOB
INJECTION\INJECTION\NAFCILLIN SODIUM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\NAFCILLIN SODIUM
INTRAMUSCULAR\INJECTION\NAFCILLIN SODIUM
INTRAMUSCULAR\POWDER, FOR SOLUTION\NAFCILLIN SODIUM
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\NAFCILLIN SODIUM
INTRAVENOUS\INJECTION, SOLUTION\NAFCILLIN SODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\NAFCILLIN
INTRAMUSCULAR\INJECTION\NAFCILLIN
INTRAMUSCULAR\POWDER, FOR SOLUTION\NAFCILLIN
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\NAFCILLIN
INTRAVENOUS\INJECTION, SOLUTION\NAFCILLIN

product(s) by strength(s)

nafcillin 1000 mg injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003381017NDABaxter Healthcare Corporation1989-10-31NAFCILLIN SODIUMINTRAVENOUSINJECTION, SOLUTIONNDA050655cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007039095ANDATeva Parenteral Medicines, Inc2014-04-08NAFCILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA200002f5e3b786-c856-4c8d-b2ab-7f756a7eda45
2007813124ANDASandoz Inc1984-08-02NAFCILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0625272222b362-a658-4462-a1ae-69a403d4002f
3007813128ANDASandoz Inc2005-09-23NAFCILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0627325df2c199-76f1-4a4d-b7a8-95d09b59e391
4007819124ANDASandoz Inc1984-08-02NAFCILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA062527c50a4dbd-534c-4639-a73f-5e0947d99a63
5007819224ANDASandoz Inc2005-09-23NAFCILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA062732d437ffc4-7898-4573-97fe-3741a01b06a5
6250210139ANDASagent Pharmaceuticals2012-10-25NAFCILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA090582eff4df0b-6889-4b6c-99a2-975f371f8743
7360000175ANDAClaris Lifesciences Inc.2012-02-01NAFCILLIN SODIUMINTRAMUSCULARINJECTIONANDA090560fda15ff5-1b77-4207-80ed-38d12c540b3f
8445670221ANDAWg Critical Care, Llc2013-01-18NAFCILLIN SODIUMINTRAMUSCULARPOWDER, FOR SOLUTIONANDA0905604d3b0076-3780-413f-9052-b23be5f18f01
9551500122ANDAAuromedics Pharma Llc2012-12-26NAFCILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA09161390717878-64cb-4ffc-90bc-7b4e81e3d1cd
10633230327ANDAApp Pharmaceuticals, Llc2011-06-30NAFCILLIN SODIUMINTRAMUSCULARPOWDER, FOR SOLUTIONANDA090002c39721a3-7b22-4720-9dbd-bc82f03d2af7

nafcillin 2000 mg injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003381019NDABaxter Healthcare Corporation1989-10-31NAFCILLIN SODIUMINTRAVENOUSINJECTION, SOLUTIONNDA050655cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813125ANDASandoz Inc1984-08-02NAFCILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0625272222b362-a658-4462-a1ae-69a403d4002f
2007813129ANDASandoz Inc2005-09-23NAFCILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0627325df2c199-76f1-4a4d-b7a8-95d09b59e391
3007819125ANDASandoz Inc1984-08-02NAFCILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA062527c50a4dbd-534c-4639-a73f-5e0947d99a63
4007819225ANDASandoz Inc2005-09-23NAFCILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA062732d437ffc4-7898-4573-97fe-3741a01b06a5
5250210140ANDASagent Pharmaceuticals2012-10-25NAFCILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA090582eff4df0b-6889-4b6c-99a2-975f371f8743
6360000176ANDAClaris Lifesciences Inc.2012-02-01NAFCILLIN SODIUMINTRAMUSCULARINJECTIONANDA090560fda15ff5-1b77-4207-80ed-38d12c540b3f
7445670222ANDAWg Critical Care, Llc2013-01-18NAFCILLIN SODIUMINTRAMUSCULARPOWDER, FOR SOLUTIONANDA0905604d3b0076-3780-413f-9052-b23be5f18f01
8551500123ANDAAuromedics Pharma Llc2012-12-26NAFCILLIN SODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA09161334821770-929c-40ea-a9e4-d4405dc869e1, 90717878-64cb-4ffc-90bc-7b4e81e3d1cd
9633230328ANDAApp Pharmaceuticals, Llc2011-06-30NAFCILLIN SODIUMINTRAMUSCULARPOWDER, FOR SOLUTIONANDA090002c39721a3-7b22-4720-9dbd-bc82f03d2af7

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA061984NAFCILLIN SODIUMTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA061984_001, ANDA061984_002, ANDA061984_003, ANDA061984_005Nafcillin Injectable Solution
2ANDA061999NALLPENTrueGLAXOSMITHKLINEANDA061999_001, ANDA061999_002, ANDA061999_003, ANDA061999_004Nafcillin Injectable Solution
3ANDA062527NAFCILLIN SODIUMSANDOZ INC1984-08-02ANDA062527_001, ANDA062527_002, ANDA062527_003, ANDA062527_004Nafcillin Injectable Solution
4ANDA062717UNIPENTrueWYETH AYERST LABORATORIES1986-12-16ANDA062717_001, ANDA062717_002, ANDA062717_004Nafcillin Injectable Solution
5ANDA062732NAFCILLIN SODIUMSANDOZ INC1986-12-23ANDA062732_001, ANDA062732_002Nafcillin Injectable Solution
6ANDA062755NALLPENTrueGLAXOSMITHKLINE1986-12-19ANDA062755_001, ANDA062755_002Nafcillin Injectable Solution
7ANDA062844NAFCILLIN SODIUMTrueWATSON LABORATORIES INC1988-10-26ANDA062844_001, ANDA062844_002, ANDA062844_003, ANDA062844_004, ANDA062844_005Nafcillin Injectable Solution
8ANDA063008NAFCILLIN SODIUMTrueWATSON LABORATORIES INC1988-09-29ANDA063008_001Nafcillin Injectable Solution
9ANDA090002NAFCILLIN SODIUMISTITUTO BIOCHIMICO ITALIANO SPA2011-06-30ANDA090002_001, ANDA090002_002Nafcillin Injectable Solution
10ANDA090005NAFCILLIN SODIUMISTITUTO BIOCHIMICO ITALIANO SPA2011-04-20ANDA090005_001Nafcillin Injectable Solution
11ANDA090560NAFCILLIN SODIUMANTIBIOTICE SA2011-10-03ANDA090560_001, ANDA090560_002Nafcillin Injectable Solution
12ANDA090580NAFCILLIN SODIUMSAGENT PHARMACEUTICALS INC2012-08-24ANDA090580_001Nafcillin Injectable Solution
13ANDA090582NAFCILLIN SODIUMSAGENT PHARMACEUTICALS INC2012-08-24ANDA090582_001, ANDA090582_002Nafcillin Injectable Solution
14ANDA091613NAFCILLIN SODIUMAUROBINDO PHARMA LTD2012-12-26ANDA091613_001, ANDA091613_002Nafcillin Injectable Solution
15ANDA091614NAFCILLIN SODIUMAUROBINDO PHARMA LTD2012-12-26ANDA091614_001Nafcillin Injectable Solution
16ANDA200002NAFCILLIN SODIUMMYLAN LABORATORIES LTD2014-04-07ANDA200002_001, ANDA200002_002Nafcillin Injectable Solution
17NDA050320UNIPENTrueWYETH AYERST LABORATORIESNDA050320_001, NDA050320_002, NDA050320_003, NDA050320_004, NDA050320_005, NDA050320_006Nafcillin Injectable Solution
18NDA050655NALLPEN IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1989-10-31NDA050655_001, NDA050655_002Nafcillin Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA061984_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseNAFCILLIN SODIUM
2ANDA061984_002discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseNAFCILLIN SODIUM
3ANDA061984_003discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseNAFCILLIN SODIUM
4ANDA061984_005discontinuedNAFCILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalseNAFCILLIN SODIUM
5ANDA061999_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseNALLPEN
6ANDA061999_002discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseNALLPEN
7ANDA061999_003discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseNALLPEN
8ANDA061999_004discontinuedNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseNALLPEN
9ANDA062527_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1984-08-02NAFCILLIN SODIUM
10ANDA062527_002RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP1984-08-02NAFCILLIN SODIUM
11ANDA062527_003RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP1984-08-02NAFCILLIN SODIUM
12ANDA062527_004RXNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONTrueAP1984-08-02NAFCILLIN SODIUM
13ANDA062717_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1986-12-16UNIPEN
14ANDA062717_002discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1986-12-16UNIPEN
15ANDA062717_004discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1986-12-16UNIPEN
16ANDA062732_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP1986-12-23NAFCILLIN SODIUM
17ANDA062732_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP1986-12-23NAFCILLIN SODIUM
18ANDA062755_001discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1986-12-19NALLPEN
19ANDA062755_002discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1986-12-19NALLPEN
20ANDA062844_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1988-10-26NAFCILLIN SODIUM
21ANDA062844_002discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1988-10-26NAFCILLIN SODIUM
22ANDA062844_003discontinuedNAFCILLIN SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalse1988-10-26NAFCILLIN SODIUM
23ANDA062844_004discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1988-10-26NAFCILLIN SODIUM
24ANDA062844_005discontinuedNAFCILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalse1988-10-26NAFCILLIN SODIUM
25ANDA063008_001discontinuedNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse1988-09-29NAFCILLIN SODIUM
26ANDA090002_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-06-30NAFCILLIN SODIUM
27ANDA090002_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-06-30NAFCILLIN SODIUM
28ANDA090005_001RXNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2011-04-20NAFCILLIN SODIUM
29ANDA090560_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-10-03NAFCILLIN SODIUM
30ANDA090560_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-10-03NAFCILLIN SODIUM
31ANDA090580_001RXNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2012-08-24NAFCILLIN SODIUM
32ANDA090582_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2012-08-24NAFCILLIN SODIUM
33ANDA090582_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2012-08-24NAFCILLIN SODIUM
34ANDA091613_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2012-12-26NAFCILLIN SODIUM
35ANDA091613_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2012-12-26NAFCILLIN SODIUM
36ANDA091614_001RXNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2012-12-26NAFCILLIN SODIUM
37ANDA200002_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2014-04-07NAFCILLIN SODIUM
38ANDA200002_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2014-04-07NAFCILLIN SODIUM
39NDA050320_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseUNIPEN
40NDA050320_002discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseUNIPEN
41NDA050320_003discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseUNIPEN
42NDA050320_004discontinuedNAFCILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalseUNIPEN
43NDA050320_005discontinuedNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseUNIPEN
44NDA050320_006discontinuedNAFCILLIN SODIUM (EQ 20GM BASE/VIAL)INJECTIONFalseUNIPEN
45NDA050655_001RXNAFCILLIN SODIUM (EQ 20MG BASE/ML)INJECTIONTrue1989-10-31NALLPEN IN PLASTIC CONTAINER
46NDA050655_002RXNAFCILLIN SODIUM (EQ 2GM BASE/100ML)INJECTIONTrue1989-10-31NALLPEN IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12222b362-a658-4462-a1ae-69a403d4002f (view SPL)Nafcillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-02-2715007813124, 007813125
234821770-929c-40ea-a9e4-d4405dc869e1 (view SPL)NAFCILLIN FOR INJECTION, USPRx onlyprescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE2014-12-251551500123
34d3b0076-3780-413f-9052-b23be5f18f01 (view SPL)Nafcillin for InjectionprescriptionHuman PrescriptionWg Critical Care, Llc2015-10-263445670221, 445670222
45df2c199-76f1-4a4d-b7a8-95d09b59e391 (view SPL)Nafcillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-03-0313007813128, 007813129
590717878-64cb-4ffc-90bc-7b4e81e3d1cd (view SPL)NAFICILLIN FOR INJECTION, USPRx onlyprescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2013-12-305551500122, 551500123
6c39721a3-7b22-4720-9dbd-bc82f03d2af7 (view SPL)Nafcillin for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-07-062633230327, 633230328
7c50a4dbd-534c-4639-a73f-5e0947d99a63 (view SPL)Nafcillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-02-2713007819124, 007819125
8cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416 (view SPL)Nafcillin Injection, USP in PL 2040 Plastic Container For Intravenous Use Only GALAXY Container (PL 2040 Plastic)prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-04-038003381017, 003381019
9d437ffc4-7898-4573-97fe-3741a01b06a5 (view SPL)Nafcillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-03-0314007819224, 007819225
10eff4df0b-6889-4b6c-99a2-975f371f8743 (view SPL)Nafcillin for Injection, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2014-10-297250210139, 250210140
11f5e3b786-c856-4c8d-b2ab-7f756a7eda45 (view SPL)Nafcillin for Injection, USPFor Intramuscular or Intravenous InjectionRx onlyprescriptionHuman PrescriptionTeva Parenteral Medicines, IncAnalysis, Label, Manufacture, Pack, Sterilize2014-04-091007039095
12fda15ff5-1b77-4207-80ed-38d12c540b3f (view SPL)Nafcillin for Injection, USPprescriptionHuman PrescriptionClaris Lifesciences Inc.MANUFACTURE, analysis2011-10-182360000175, 360000176

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