FDA.reportPublic FDA data

Azithromycin

Product NDC
65862-642
11-digit product format
658620642
Labeler code
65862
Product ID
65862-642_db155bb5-7adc-494a-be66-a2e8e4a45fe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA207398
Marketing category
ANDA
Marketing start
2018-07-05
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656, 308460, 749780, 749783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-642-30Azithromycin30 in 1 BOTTLETABLET, FILM COATED308
65862-642-64Azithromycin1 in 1 CARTONTABLET, FILM COATED18
65862-642-64Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED38
65862-642-90Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED38
65862-642-90Azithromycin3 in 1 CARTONTABLET, FILM COATED38

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-642AZITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 5 package rows20240806_795c13cd-e9ca-481b-9fa9-2890bdf9dac8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN77c5e4c6-6d16-40fe-bf36-cb441348f39b11
248656azithromycin 500 MG Oral TabletSCD77c5e4c6-6d16-40fe-bf36-cb441348f39b11
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY77c5e4c6-6d16-40fe-bf36-cb441348f39b11
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK795c13cd-e9ca-481b-9fa9-2890bdf9dac88
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK795c13cd-e9ca-481b-9fa9-2890bdf9dac88
308460azithromycin 250 MG Oral TabletPSN795c13cd-e9ca-481b-9fa9-2890bdf9dac88
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN795c13cd-e9ca-481b-9fa9-2890bdf9dac88
248656azithromycin 500 MG Oral TabletPSN795c13cd-e9ca-481b-9fa9-2890bdf9dac88
248656azithromycin 500 MG Oral TabletPSN24c07398-84ad-48e2-9625-e9073c28fb738
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN795c13cd-e9ca-481b-9fa9-2890bdf9dac88
308460azithromycin 250 MG Oral TabletSCD795c13cd-e9ca-481b-9fa9-2890bdf9dac88
248656azithromycin 500 MG Oral TabletSCD795c13cd-e9ca-481b-9fa9-2890bdf9dac88
248656azithromycin 500 MG Oral TabletSCD24c07398-84ad-48e2-9625-e9073c28fb738
749783azithromycin 250 MG Oral Tablet 6 Count PackSY795c13cd-e9ca-481b-9fa9-2890bdf9dac88
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY24c07398-84ad-48e2-9625-e9073c28fb738
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY795c13cd-e9ca-481b-9fa9-2890bdf9dac88
749780azithromycin 500 MG Oral Tablet 3 Count PackSY795c13cd-e9ca-481b-9fa9-2890bdf9dac88
248656azithromycin 500 MG Oral TabletPSN003307c5-3f73-4a5d-a704-bfdea3c656e87
248656azithromycin 500 MG Oral TabletSCD003307c5-3f73-4a5d-a704-bfdea3c656e87
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY003307c5-3f73-4a5d-a704-bfdea3c656e87
248656azithromycin 500 MG Oral TabletPSNa81212ef-76b6-4bd7-8706-3d2b05ee34f96
248656azithromycin 500 MG Oral TabletSCDa81212ef-76b6-4bd7-8706-3d2b05ee34f96
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYa81212ef-76b6-4bd7-8706-3d2b05ee34f96
248656azithromycin 500 MG Oral TabletPSN94e17ae5-0871-67a0-e053-2995a90ae0ae5
248656azithromycin 500 MG Oral TabletSCD94e17ae5-0871-67a0-e053-2995a90ae0ae5
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY94e17ae5-0871-67a0-e053-2995a90ae0ae5
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK2fd25741-f014-3999-e063-6394a90acdd03
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
248656azithromycin 500 MG Oral TabletPSN2fd25741-f014-3999-e063-6394a90acdd03
248656azithromycin 500 MG Oral TabletPSN8e6e11fb-eb9e-28ec-e053-2a95a90aa1a33
248656azithromycin 500 MG Oral TabletPSN8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
248656azithromycin 500 MG Oral TabletPSN1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
248656azithromycin 500 MG Oral TabletPSN9270e676-3382-6483-e053-2a95a90a556e3
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN2fd25741-f014-3999-e063-6394a90acdd03
248656azithromycin 500 MG Oral TabletSCD9270e676-3382-6483-e053-2a95a90a556e3
248656azithromycin 500 MG Oral TabletSCD8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
248656azithromycin 500 MG Oral TabletSCD2fd25741-f014-3999-e063-6394a90acdd03
248656azithromycin 500 MG Oral TabletSCD8e6e11fb-eb9e-28ec-e053-2a95a90aa1a33
248656azithromycin 500 MG Oral TabletSCD1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY8e6e11fb-eb9e-28ec-e053-2a95a90aa1a33
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY9270e676-3382-6483-e053-2a95a90a556e3
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY2fd25741-f014-3999-e063-6394a90acdd03
749780azithromycin 500 MG Oral Tablet 3 Count PackSY1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
749780azithromycin 500 MG Oral Tablet 3 Count PackSY8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
749780azithromycin 500 MG Oral Tablet 3 Count PackSY2fd25741-f014-3999-e063-6394a90acdd03
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK25f2d819-ae38-4061-a897-bbcfce3739bf2
248656azithromycin 500 MG Oral TabletPSN25f2d819-ae38-4061-a897-bbcfce3739bf2
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN25f2d819-ae38-4061-a897-bbcfce3739bf2
248656azithromycin 500 MG Oral TabletSCD25f2d819-ae38-4061-a897-bbcfce3739bf2
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY25f2d819-ae38-4061-a897-bbcfce3739bf2
749780azithromycin 500 MG Oral Tablet 3 Count PackSY25f2d819-ae38-4061-a897-bbcfce3739bf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-642-126586206421212500 TABLET, FILM COATED in 1 BAG (65862-642-12)16-SEP-20Current
65862-642-306586206423030 TABLET, FILM COATED in 1 BOTTLE (65862-642-30) 2018-07-050000-00-00NoNoCurrent
65862-642-556586206425515000 TABLET, FILM COATED in 1 BAG (65862-642-55)16-SEP-20Current
65862-642-64658620642641 BLISTER PACK in 1 CARTON (65862-642-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-07-050000-00-00NoNoCurrent
65862-642-90658620642903 BLISTER PACK in 1 CARTON (65862-642-90) / 3 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2018-07-050000-00-00NoNoCurrent