Azithromycin Oral Suspension

Brand(s)
Zithromax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2014-12-15)
Oldest Current Product
1995-10-19
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SUSPENSION\AZITHROMYCIN
FDAOB
ORAL\FOR SUSPENSION\AZITHROMYCIN
SPL Active
ORAL\POWDER, FOR SUSPENSION\AZITHROMYCIN DIHYDRATE
ORAL\POWDER, FOR SUSPENSION\AZITHROMYCIN MONOHYDRATE
ORAL\POWDER, FOR SUSPENSION\AZITHROMYCIN, UNSPECIFIED FORM
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\AZITHROMYCIN ANHYDROUS
ORAL\POWDER, FOR SUSPENSION\AZITHROMYCIN, UNSPECIFIED FORM

product(s) by strength(s)

azithromycin 16.7 mg/ml oral suspension

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597623051NDAGreenstone Llc1999-02-12AZITHROMYCIN DIHYDRATEORALPOWDER, FOR SUSPENSIONNDA050693d470695c-c0d7-4361-8783-45f58a932ac4

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685938NDAPhysicians Total Care, Inc.2008-09-08AZITHROMYCIN DIHYDRATEORALPOWDER, FOR SUSPENSION597623051NDA0506935a96f4e1-6b80-42a2-8d85-95a1ff892099
2682583051NDADispensing Solutions, Inc.1999-02-12AZITHROMYCIN, UNSPECIFIED FORMORALPOWDER, FOR SUSPENSION597623051NDA05069353e2801a-323d-448e-8278-92d672904b0f
3687880713NDAPreferred Pharmaceuticals, Inc.1999-02-12AZITHROMYCIN DIHYDRATEORALPOWDER, FOR SUSPENSION597623051NDA05069386071c7f-9f11-4783-9492-22beb55682e6

azithromycin 20 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000693110ZithromaxNDAPfizer Labs1995-10-19AZITHROMYCIN DIHYDRATEORALPOWDER, FOR SUSPENSIONNDA050710db52b91e-79f7-4cc1-9564-f2eee8e31c45

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932027ANDATeva Pharmaceuticals Usa Inc2010-12-28AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSIONANDA0652463209b147-11ce-4eeb-8427-5f8e6fb2c83d
2000937148ANDATeva Pharmaceuticals Usa Inc2008-09-22AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSIONANDA0654194d8b1cba-b6ed-4036-8307-28da2322ccd5
3597623110NDA AUTHORIZED GENERICGreenstone Llc1995-10-19AZITHROMYCIN DIHYDRATEORALPOWDER, FOR SUSPENSIONNDA050710f5b6daad-b5a9-462d-8e10-db22a7af1c72

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950548ANDARebel Distributors Corp2008-06-24AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSION000937148ANDA06541958b72e4c-f419-4a70-b894-93a5804d9993
2548685647NDAPhysicians Total Care, Inc.2006-08-01AZITHROMYCIN, UNSPECIFIED FORMORALPOWDER, FOR SUSPENSION597623110NDA050710966c8f58-fde1-4af0-964b-c0bddbb05b36
3687889045ANDAPreferred Pharmaceuticals, Inc.2011-03-10AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSION000937148ANDA06541951835dc6-68c7-44b0-980c-f9b38b8d7203
4687889958ANDAPreferred Pharmaceuticals, Inc.2012-01-10AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSION000932027ANDA065246035ce971-cf46-40c0-9b2f-ae52ab4e3468

azithromycin 40 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000693120ZithromaxNDAPfizer Labs1995-10-19AZITHROMYCIN DIHYDRATEORALPOWDER, FOR SUSPENSIONNDA050710db52b91e-79f7-4cc1-9564-f2eee8e31c45
2000693130ZithromaxNDAPfizer Labs1995-10-19AZITHROMYCIN DIHYDRATEORALPOWDER, FOR SUSPENSIONNDA050710db52b91e-79f7-4cc1-9564-f2eee8e31c45

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932026ANDATeva Pharmaceuticals Usa Inc2010-12-17AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSIONANDA0652463209b147-11ce-4eeb-8427-5f8e6fb2c83d
2000937149ANDATeva Pharmaceuticals Usa Inc2008-09-22AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSIONANDA0654194d8b1cba-b6ed-4036-8307-28da2322ccd5
3597623120NDA AUTHORIZED GENERICGreenstone Llc1995-10-19AZITHROMYCIN DIHYDRATEORALPOWDER, FOR SUSPENSIONNDA050710f5b6daad-b5a9-462d-8e10-db22a7af1c72
4597623130NDA AUTHORIZED GENERICGreenstone Llc1995-10-19AZITHROMYCIN DIHYDRATEORALPOWDER, FOR SUSPENSIONNDA050710f5b6daad-b5a9-462d-8e10-db22a7af1c72
5597623140NDA AUTHORIZED GENERICGreenstone Llc1995-10-19AZITHROMYCIN DIHYDRATEORALPOWDER, FOR SUSPENSIONNDA050710f5b6daad-b5a9-462d-8e10-db22a7af1c72

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950549ANDARebel Distributors Corp2008-06-24AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSION000937149ANDA06541958b72e4c-f419-4a70-b894-93a5804d9993
2548685648NDAPhysicians Total Care, Inc.2006-08-03AZITHROMYCIN, UNSPECIFIED FORMORALPOWDER, FOR SUSPENSION597623120NDA050710966c8f58-fde1-4af0-964b-c0bddbb05b36
3581180020ANDAClinical Solutions Wholesale2010-12-17AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSION000932026ANDA0652462c4b6512-0be3-4e5d-8aa6-1809f8027352
4619190382ANDADirect Rx2014-01-01AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSION000932026ANDA0652465c756d25-d561-4cd2-9da3-89aacc72a154
5631870093ANDAProficient Rx Lp2010-12-17AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSION000932026ANDA06524644134421-cb0b-4e85-a3c8-d58bdb476fad
6661160524ANDAMedvantx, Inc.2008-09-22AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSION000937149ANDA0654194e9ac94f-4d85-4731-8b7f-6188209b4a9c
7687889046ANDAPreferred Pharmaceuticals, Inc.2011-03-10AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSION000937149ANDA06541951835dc6-68c7-44b0-980c-f9b38b8d7203
8687889959ANDAPreferred Pharmaceuticals, Inc.2012-01-10AZITHROMYCIN MONOHYDRATEORALPOWDER, FOR SUSPENSION000932026ANDA065246035ce971-cf46-40c0-9b2f-ae52ab4e3468

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA065246AZITHROMYCINPLIVA INC2006-07-05ANDA065246_001, ANDA065246_002
2ANDA065297AZITHROMYCINTrueSANDOZ INC2006-09-18ANDA065297_001, ANDA065297_002
3ANDA065419AZITHROMYCINTEVA PHARMACEUTICALS USA2008-06-24ANDA065419_001, ANDA065419_002
4ANDA065488AZITHROMYCINLUPIN LTD2015-05-15ANDA065488_001, ANDA065488_002
5NDA050693ZITHROMAXPFIZER CENTRAL RESEARCH1994-09-28p6268489NDA050693_001
6NDA050710ZITHROMAXPFIZER CHEMICALS DIV PFIZER INC1995-10-19p6268489NDA050710_001, NDA050710_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065246_001RXAZITHROMYCIN (EQ 200MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2006-07-05AZITHROMYCIN
2ANDA065246_002RXAZITHROMYCIN (EQ 100MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2006-07-05AZITHROMYCIN
3ANDA065297_001discontinuedAZITHROMYCIN (EQ 100MG BASE/5ML)ORALFOR SUSPENSIONFalse2006-09-18AZITHROMYCIN
4ANDA065297_002discontinuedAZITHROMYCIN (EQ 200MG BASE/5ML)ORALFOR SUSPENSIONFalse2006-09-18AZITHROMYCIN
5ANDA065419_001RXAZITHROMYCIN (EQ 100MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2008-06-24AZITHROMYCIN
6ANDA065419_002RXAZITHROMYCIN (EQ 200MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2008-06-24AZITHROMYCIN
7ANDA065488_001RXAZITHROMYCIN (EQ 100MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2015-05-15AZITHROMYCIN
8ANDA065488_002RXAZITHROMYCIN (EQ 200MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2015-05-15AZITHROMYCIN
9NDA050693_001RXAZITHROMYCIN (EQ 1GM BASE/PACKET)ORALFOR SUSPENSIONTrue1994-09-28ZITHROMAX
10NDA050710_001RXAZITHROMYCIN (EQ 100MG BASE/5ML)ORALFOR SUSPENSIONFalseAB1995-10-19ZITHROMAX
11NDA050710_002RXAZITHROMYCIN (EQ 200MG BASE/5ML)ORALFOR SUSPENSIONTrueAB1995-10-19ZITHROMAX

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1035ce971-cf46-40c0-9b2f-ae52ab4e3468 (view SPL)AZITHROMYCIN FOR ORAL SUSPENSION USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-07-103687889958, 687889959
22c4b6512-0be3-4e5d-8aa6-1809f8027352 (view SPL)AZITHROMYCIN FOR ORAL SUSPENSION USPprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL2013-11-131581180020
33209b147-11ce-4eeb-8427-5f8e6fb2c83d (view SPL)These highlights do not include all the information needed to use azithromycin for oral suspension USP safely and effectively. See full prescribing information for azithromycin for oral suspension USP. AZITHROMYCIN for oral suspension USP for oral useInitial U.S. Approval: 1991prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-08-137000932026, 000932027
444134421-cb0b-4e85-a3c8-d58bdb476fad (view SPL)AZITHROMYCIN FOR ORAL SUSPENSION USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-06-063631870093
54d8b1cba-b6ed-4036-8307-28da2322ccd5 (view SPL)These highlights do not include all the information needed to use AZITHROMYCIN for oral suspension USP safely and effectively. See full prescribing information for AZITHROMYCIN for oral suspension USP. AZITHROMYCIN for oral suspensionInitial U.S. Approval: 1991prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-06-2612000937148, 000937149
64e9ac94f-4d85-4731-8b7f-6188209b4a9c (view SPL)Azithromycin for Oral Suspension USP 7148 7149 Rx onlyprescriptionHuman PrescriptionMedvantx, Inc.REPACK2013-05-161661160524
751835dc6-68c7-44b0-980c-f9b38b8d7203 (view SPL)Azithromycin for Oral Suspension USP 7148 7149 Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-07-105687889045, 687889046
853e2801a-323d-448e-8278-92d672904b0f (view SPL)AZITHROMYCIN azithromycin tablets and azithromycin for oral suspensionprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-10-032682583051
958b72e4c-f419-4a70-b894-93a5804d9993 (view SPL)AZITHROMYCIN FOR ORAL SUSPENSION, USP71487149Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-092216950548, 216950549
105a96f4e1-6b80-42a2-8d85-95a1ff892099 (view SPL)AZITHROMYCIN azithromycin tablets and azithromycin for oral suspensionprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-05-292548685938
115c756d25-d561-4cd2-9da3-89aacc72a154 (view SPL)AZITHROMYCINprescriptionHuman PrescriptionDirect Rxrelabel2015-08-063619190382
1286071c7f-9f11-4783-9492-22beb55682e6 (view SPL)AZITHROMYCIN azithromycin tablets and azithromycin for oral suspensionprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-07-107687880713
13966c8f58-fde1-4af0-964b-c0bddbb05b36 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-12-232548685647, 548685648
14b749df83-49b0-433e-8a62-589a048dd716 (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) 600 mg Tablets and Oral SuspensionInitial U.S. Approval: 1991prescriptionHuman PrescriptionPfizer LabsAPI MANUFACTURE, MANUFACTURE, PACK2014-12-1013000693051, 000693080Azithromycin Oral Tablet
15d470695c-c0d7-4361-8783-45f58a932ac4 (view SPL)These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg Tablets and Oral Suspension Initial U.S. Approval: 1991prescriptionHuman PrescriptionGreenstone LlcAPI MANUFACTURE, MANUFACTURE, PACK2015-05-3018597623051, 597623080Azithromycin Oral Tablet
16db52b91e-79f7-4cc1-9564-f2eee8e31c45 (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) 250 mg and 500 mg Tablets and Oral Suspension Initial U.S. Approval: 1991prescriptionHuman PrescriptionPfizer LabsAPI MANUFACTURE, MANUFACTURE2014-12-1515000693110, 000693120, 000693130, 000693060, 000693070, 000693140Azithromycin Oral Tablet
17f5b6daad-b5a9-462d-8e10-db22a7af1c72 (view SPL)These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 250 mg and 500 mg Tablets and Oral Suspension Initial U.S. Approval: 1991prescriptionHuman PrescriptionGreenstone LlcAPI MANUFACTURE, MANUFACTURE, PACK2015-04-2215597623110, 597623120, 597623130, 597623140, 597623060, 597623070Azithromycin Oral Tablet

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