Azithromycin Injection

Brand(s)
Zithromax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-05-05)
Oldest Current Product
1997-01-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTION\AZITHROMYCIN
FDAOB
INJECTION\INJECTION\AZITHROMYCIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AZITHROMYCIN DIHYDRATE
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AZITHROMYCIN MONOHYDRATE
INTRAVENOUS\INJECTION\AZITHROMYCIN MONOHYDRATE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AZITHROMYCIN ANHYDROUS
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AZITHROMYCIN, UNSPECIFIED FORM
INTRAVENOUS\INJECTION\AZITHROMYCIN, UNSPECIFIED FORM

product(s) by strength(s)

azithromycin 500 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000693150ZithromaxNDAPfizer Labs1997-01-30AZITHROMYCIN DIHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0507333b631aa1-2d46-40bc-a614-d698301ea4f9

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090144ANDAHospira, Inc.2009-06-26AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065500, ANDA065511918925cc-8da9-4016-998c-c06ed4676ae4, d2f4907f-b952-403b-229e-cc5b8327a773
2100190648NDA AUTHORIZED GENERICBaxter Healthcare Corporation1997-01-01AZITHROMYCIN DIHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA05073365d8adaa-04c8-4c5e-ae57-2fbae0979178
3250210112ANDASagent Pharmaceuticals2009-05-01AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065506efdef52a-ccc9-4612-bd91-ff5ca55a8193
4551500174ANDAAuromedics Pharma Llc2015-06-19AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA2032947b81436e-d14a-4353-a22d-253f45e2e576
5605056076ANDAApotex Corp2010-04-25AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTIONANDA065501679af699-714d-a3a3-674b-fc9ae4474a9a
6627560512ANDASun Pharmaceutical Industries Limited2013-04-03AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0909236a22beb6-57e8-480d-97b5-44d9dbfabf93
7633230398ANDAApp Pharmaceuticals, Llc2006-03-20AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06517962f6f327-3fef-49f0-ae90-078356d002b5, 9ad099d5-5c57-4855-98a4-e03fb4629dbf, b69917c0-95d5-4b29-b0e3-07054a4fd79f
8680830199ANDAGland Pharma Limited2009-11-09AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06550155051e03-b6dc-4bc6-87c1-e4fb84b61fa3

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1501110794ANDAPliva Inc.2007-08-17AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06526513cbc9d9-4e59-4731-b9ef-41084859fecf
2551545759ANDACardinal Health2011-01-31AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION501110794ANDA065265284f1e3c-45e4-40fc-a56a-bfacec331016

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551549382ANDACardinal Health2006-03-20AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION633230398ANDA06517991023a75-91c1-4d64-9e4e-a03bd8972032
2551549385ANDACardinal Health2009-12-10AZITHROMYCIN MONOHYDRATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION633230398ANDA0651795673a9ed-58f2-464c-b2e9-6dc46077cb69

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA065179AZITHROMYCINFRESENIUS KABI USA LLC2005-12-13ANDA065179_001
2ANDA065265AZITHROMYCINTruePLIVA HRVATSKA DOO2007-01-18ANDA065265_001
3ANDA065500AZITHROMYCINHOSPIRA INC2009-06-26ANDA065500_001
4ANDA065501AZITHROMYCINGLAND PHARMA LTD2009-11-09ANDA065501_001
5ANDA065506AZITHROMYCINSAGENT STRIDES LLC2009-03-24ANDA065506_001
6ANDA065511AZITHROMYCINHOSPIRA INC2009-06-26ANDA065511_001
7ANDA090923AZITHROMYCINSUN PHARMACEUTICAL INDUSTRIES LTD2013-04-02ANDA090923_001
8ANDA203294AZITHROMYCINAUROBINDO PHARMA LTD2015-06-19ANDA203294_001
9NDA050733ZITHROMAXPFIZER INC1997-01-30p6268489NDA050733_001
10NDA050809AZITHROMYCINTrueTEVA PARENTERAL MEDICINES INC2006-12-19NDA050809_001, NDA050809_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA065179_001RXAZITHROMYCIN (EQ 500MG BASE/VIAL)INJECTIONFalseAP2005-12-13AZITHROMYCIN
2ANDA065265_001discontinuedAZITHROMYCIN (EQ 500MG BASE/VIAL)INJECTIONFalse2007-01-18AZITHROMYCIN
3ANDA065500_001RXAZITHROMYCIN (EQ 500MG BASE/VIAL)INJECTIONFalseAP2009-06-26AZITHROMYCIN
4ANDA065501_001RXAZITHROMYCIN (EQ 500MG BASE/VIAL)INJECTIONFalseAP2009-11-09AZITHROMYCIN
5ANDA065506_001RXAZITHROMYCIN (EQ 500MG BASE/VIAL)INJECTIONFalseAP2009-03-24AZITHROMYCIN
6ANDA065511_001RXAZITHROMYCIN (EQ 500MG BASE/VIAL)INJECTIONFalseAP2009-06-26AZITHROMYCIN
7ANDA090923_001RXAZITHROMYCIN (EQ 500MG BASE/VIAL)INJECTIONFalseAP2013-04-02AZITHROMYCIN
8ANDA203294_001RXAZITHROMYCIN (EQ 500MG BASE/VIAL)INJECTIONFalseAP2015-06-19AZITHROMYCIN
9NDA050733_001RXAZITHROMYCIN (EQ 500MG BASE/VIAL)INJECTIONTrueAP1997-01-30ZITHROMAX
10NDA050809_001discontinuedAZITHROMYCIN (EQ 500MG BASE/VIAL)INJECTIONFalse2006-12-19AZITHROMYCIN
11NDA050809_002discontinuedAZITHROMYCIN (EQ 2.5GM BASE/VIAL)INJECTIONFalse2006-12-19AZITHROMYCIN

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6268489 (view patent)2018-07-31NDA050733, NDA050693, NDA050710, NDA050711, NDA050730, NDA050784, NDA050797Azithromycin Oral Suspension
Azithromycin Extended Release Suspension
Azithromycin Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
113cbc9d9-4e59-4731-b9ef-41084859fecf (view SPL)AZITHROMYCIN FOR INJECTION USPprescriptionHuman PrescriptionPliva Inc.2013-03-044501110794
2284f1e3c-45e4-40fc-a56a-bfacec331016 (view SPL)AZITHROMYCIN FOR INJECTIONprescriptionHuman PrescriptionCardinal HealthREPACK2011-08-041551545759
33b631aa1-2d46-40bc-a614-d698301ea4f9 (view SPL)These highlights do not include all the information needed to use ZITHROMAX safely and effectively. See full prescribing information for ZITHROMAX. ZITHROMAX (azithromycin) for IV infusion onlyInitial U.S. Approval: 1991prescriptionHuman PrescriptionPfizer LabsAPI MANUFACTURE, MANUFACTURE2015-05-0517000693150
455051e03-b6dc-4bc6-87c1-e4fb84b61fa3 (view SPL)These highlights do not include all the information needed to useAZITHROMYCIN for Injection, USP safely and effectively. See full prescribing information for AZITHROMYCIN for Injection, USP. AZITHROMYCIN for Injection, USP for IV infusion onlyInitial U.S. Approval: 1991prescriptionHuman PrescriptionGland Pharma LimitedANALYSIS, MANUFACTURE2014-10-015680830199
55673a9ed-58f2-464c-b2e9-6dc46077cb69 (view SPL)Azithromycin for Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-04-244551549385
662f6f327-3fef-49f0-ae90-078356d002b5 (view SPL)Azithromycin for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-01-081633230398
765d8adaa-04c8-4c5e-ae57-2fbae0979178 (view SPL)These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN for IV infusion onlyInitial U.S. Approval: 1991prescriptionHuman PrescriptionBaxter Healthcare CorporationAPI MANUFACTURE, MANUFACTURE2014-11-197100190648
8679af699-714d-a3a3-674b-fc9ae4474a9a (view SPL)Azithromycin for InjectionprescriptionHuman PrescriptionApotex Corpmanufacture2010-08-251605056076
96a22beb6-57e8-480d-97b5-44d9dbfabf93 (view SPL)These highlights do not include all the information needed to use AZITHROMYCIN for injection, USP safely and effectively. See full prescribing information for AZITHROMYCIN for injection, USP. AZITHROMYCIN for injection, USP for intravenous infusion onlyInitial U.S. Approval: 1991prescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-03-268627560512
107b81436e-d14a-4353-a22d-253f45e2e576 (view SPL)These highlights do not include all the information needed to use azithromycin for injection safely and effectively. See full prescribing information for azithromycin for injection. Azithromycin for Injection, USP for I.V. infusion onlyInitial U.S. Approval: 1991prescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, MANUFACTURE2015-06-242551500174
118d24bacb-feff-4c6a-b8df-625e1435387a (view SPL)These highlights do not include all the information needed to use ZITHROMAX safely and effectively. See full prescribing information for ZITHROMAX. ZITHROMAX (azithromycin for injection) for IV infusion onlyInitial U.S. Approval: 1991prescriptionHuman PrescriptionPfizer LabsAPI MANUFACTURE, MANUFACTURE, PACK2015-05-297000690400
1291023a75-91c1-4d64-9e4e-a03bd8972032 (view SPL)Azithromycin for Injection USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-11-182551549382
13918925cc-8da9-4016-998c-c06ed4676ae4 (view SPL)These highlights do not include all the information needed to use Azithromycin safely and effectively. See full prescribing information for Azithromycin.AZITHROMYCIN for Injection, for intravenous infusion onlyInitial U.S. Approval: 2009prescriptionHuman PrescriptionHospira, Inc.2015-06-0515004090144
149ad099d5-5c57-4855-98a4-e03fb4629dbf (view SPL)Azithromycin for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-06-261633230398
15b69917c0-95d5-4b29-b0e3-07054a4fd79f (view SPL)These highlights do not include all the information needed to use Azithromycin for Injection, USP safely and effectively. See full prescribing information for Azithromycin for Injection, USP. Azithromycin for Injection, USP, for intravenous infusion only Initial U.S. Approval: 1991prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-10-296633230398
16d2f4907f-b952-403b-229e-cc5b8327a773 (view SPL)These highlights do not include all the information needed to use Azithromycin safely and effectively. See full prescribing information for Azithromycin.AZITHROMYCIN for Injection, for intravenous infusion onlyInitial U.S. Approval: 2009prescriptionHuman PrescriptionHospira, Inc.2015-06-0517004090144
17efdef52a-ccc9-4612-bd91-ff5ca55a8193 (view SPL)These highlights do not include all the information needed to use Azithromycin for Injection, USP safely and effectively. See full prescribing information for Azithromycin for Injection, USP.Azithromycin for Injection, USP for IV infusion only Initial U.S. Approval: 1991prescriptionHuman PrescriptionSagent Pharmaceuticals2014-08-1212250210112

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