FDA.reportPublic FDA data

Azithromycin

Product NDC
65862-641
11-digit product format
658620641
Labeler code
65862
Product ID
65862-641_db155bb5-7adc-494a-be66-a2e8e4a45fe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA207370
Marketing category
ANDA
Marketing start
2018-07-05
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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 DIHYDRATE250 mg/1

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-641-01Azithromycin100 in 1 BOTTLETABLET, FILM COATED1008
65862-641-05Azithromycin500 in 1 BOTTLETABLET, FILM COATED5008
65862-641-30Azithromycin30 in 1 BOTTLETABLET, FILM COATED308
65862-641-50Azithromycin50 in 1 BOTTLETABLET, FILM COATED508
65862-641-63Azithromycin3 in 1 CARTONTABLET, FILM COATED38
65862-641-63Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED68
65862-641-69Azithromycin1 in 1 CARTONTABLET, FILM COATED18
65862-641-69Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED68

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-641AZITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 8 package rows20240806_795c13cd-e9ca-481b-9fa9-2890bdf9dac8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSN5f144e92-c9eb-420a-9bb8-4265a9f20a9817
308460azithromycin 250 MG Oral TabletSCD5f144e92-c9eb-420a-9bb8-4265a9f20a9817
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK4278e306-bc26-4282-93ce-f1405e0b5d4a9
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK47a8fd64-5a3d-490e-8ca8-5e6721c830cf9
308460azithromycin 250 MG Oral TabletPSN4278e306-bc26-4282-93ce-f1405e0b5d4a9
308460azithromycin 250 MG Oral TabletPSN47a8fd64-5a3d-490e-8ca8-5e6721c830cf9
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN4278e306-bc26-4282-93ce-f1405e0b5d4a9
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN47a8fd64-5a3d-490e-8ca8-5e6721c830cf9
308460azithromycin 250 MG Oral TabletSCD4278e306-bc26-4282-93ce-f1405e0b5d4a9
308460azithromycin 250 MG Oral TabletSCD47a8fd64-5a3d-490e-8ca8-5e6721c830cf9
749783azithromycin 250 MG Oral Tablet 6 Count PackSY47a8fd64-5a3d-490e-8ca8-5e6721c830cf9
749783azithromycin 250 MG Oral Tablet 6 Count PackSY4278e306-bc26-4282-93ce-f1405e0b5d4a9
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
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
749783azithromycin 250 MG Oral Tablet 6 Count PackSY795c13cd-e9ca-481b-9fa9-2890bdf9dac88
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY795c13cd-e9ca-481b-9fa9-2890bdf9dac88
749780azithromycin 500 MG Oral Tablet 3 Count PackSY795c13cd-e9ca-481b-9fa9-2890bdf9dac88
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783azithromycin 250 MG Oral Tablet 6 Count PackSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780azithromycin 500 MG Oral Tablet 3 Count PackSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletPSNa9cdb5ae-2aeb-c598-e053-2a95a90a80626
308460azithromycin 250 MG Oral TabletSCDa9cdb5ae-2aeb-c598-e053-2a95a90a80626
308460azithromycin 250 MG Oral TabletPSNcb40f4cf-15ae-47ab-8e0a-979467fa0d9e5
308460azithromycin 250 MG Oral TabletSCDcb40f4cf-15ae-47ab-8e0a-979467fa0d9e5
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK4eec460d-5ba8-4614-8700-219a9b4fc3854
308460azithromycin 250 MG Oral TabletPSN4eec460d-5ba8-4614-8700-219a9b4fc3854
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN4eec460d-5ba8-4614-8700-219a9b4fc3854
308460azithromycin 250 MG Oral TabletSCD4eec460d-5ba8-4614-8700-219a9b4fc3854
749783azithromycin 250 MG Oral Tablet 6 Count PackSY4eec460d-5ba8-4614-8700-219a9b4fc3854
308460azithromycin 250 MG Oral TabletPSN896cce83-23ac-f4ed-e053-2a95a90ad1073
308460azithromycin 250 MG Oral TabletSCD896cce83-23ac-f4ed-e053-2a95a90ad1073
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK5a8f7836-17ef-4944-a86f-dc162a5c8e551
308460azithromycin 250 MG Oral TabletPSNdc8e486e-619f-4ee1-e053-2a95a90a79401
308460azithromycin 250 MG Oral TabletPSN3c4861f2-825e-4e3b-9907-9658a849079e1
308460azithromycin 250 MG Oral TabletPSNf05c3199-e5cd-3a89-e053-2995a90acf5f1
308460azithromycin 250 MG Oral TabletPSN5a8f7836-17ef-4944-a86f-dc162a5c8e551
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN5a8f7836-17ef-4944-a86f-dc162a5c8e551
308460azithromycin 250 MG Oral TabletSCD5a8f7836-17ef-4944-a86f-dc162a5c8e551
308460azithromycin 250 MG Oral TabletSCDdc8e486e-619f-4ee1-e053-2a95a90a79401
308460azithromycin 250 MG Oral TabletSCDf05c3199-e5cd-3a89-e053-2995a90acf5f1
308460azithromycin 250 MG Oral TabletSCD3c4861f2-825e-4e3b-9907-9658a849079e1
749783azithromycin 250 MG Oral Tablet 6 Count PackSY5a8f7836-17ef-4944-a86f-dc162a5c8e551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-641-0165862064101100 TABLET, FILM COATED in 1 BOTTLE (65862-641-01) 2018-07-050000-00-00NoNoCurrent
65862-641-0565862064105500 TABLET, FILM COATED in 1 BOTTLE (65862-641-05) 2018-07-050000-00-00NoNoCurrent
65862-641-256586206412525000 TABLET, FILM COATED in 1 BAG (65862-641-25)16-SEP-20Current
65862-641-306586206413030 TABLET, FILM COATED in 1 BOTTLE (65862-641-30) 2018-07-050000-00-00NoNoCurrent
65862-641-506586206415050 TABLET, FILM COATED in 1 BOTTLE (65862-641-50) 2018-07-050000-00-00NoNoCurrent
65862-641-556586206415515000 TABLET, FILM COATED in 1 BAG (65862-641-55)16-SEP-20Current
65862-641-63658620641633 BLISTER PACK in 1 CARTON (65862-641-63) / 6 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2018-07-050000-00-00NoNoCurrent
65862-641-69658620641691 BLISTER PACK in 1 CARTON (65862-641-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-07-050000-00-00NoNoCurrent