FDA.reportPublic FDA data

Azithromycin

Product NDC
0781-8089
11-digit product format
007818089
Labeler code
0781
Product ID
0781-8089_a43a036c-9af9-4429-b0c0-731001003fea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065211
Marketing category
ANDA
Marketing start
2005-11-14
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin
Listing expiration
2026-12-31

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
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
0781-8089-26Azithromycin6 in 1 CARTONTABLET, FILM COATED64
0781-8089-26Azithromycin1 in 1 DOSE PACKTABLET, FILM COATED14
0781-8089-31Azithromycin30 in 1 BOTTLETABLET, FILM COATED304
0781-8089-69Azithromycin5 in 1 CARTONTABLET, FILM COATED54
0781-8089-69Azithromycin10 in 1 BLISTER PACKTABLET, FILM COATED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-8089AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]4Current NDC, Legacy NDC, 5 package rows20221202_ec619299-e0ef-44dd-acdb-8c53bbfc5b8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
308460azithromycin 250 MG Oral TabletPSNec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
248656azithromycin 500 MG Oral TabletPSNec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
308460azithromycin 250 MG Oral TabletSCDec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
248656azithromycin 500 MG Oral TabletSCDec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749783azithromycin 250 MG Oral Tablet 6 Count PackSYec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749780azithromycin 500 MG Oral Tablet 3 Count PackSYec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK60ec2020-148b-4a2a-96f2-dd09c590ecbb3
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK38942011-f86b-4e42-a4ca-05a70d9dd3d93
308460azithromycin 250 MG Oral TabletPSN60ec2020-148b-4a2a-96f2-dd09c590ecbb3
308460azithromycin 250 MG Oral TabletPSN38942011-f86b-4e42-a4ca-05a70d9dd3d93
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN60ec2020-148b-4a2a-96f2-dd09c590ecbb3
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN38942011-f86b-4e42-a4ca-05a70d9dd3d93
308460azithromycin 250 MG Oral TabletSCD60ec2020-148b-4a2a-96f2-dd09c590ecbb3
308460azithromycin 250 MG Oral TabletSCD38942011-f86b-4e42-a4ca-05a70d9dd3d93
749783azithromycin 250 MG Oral Tablet 6 Count PackSY38942011-f86b-4e42-a4ca-05a70d9dd3d93
749783azithromycin 250 MG Oral Tablet 6 Count PackSY60ec2020-148b-4a2a-96f2-dd09c590ecbb3
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf4c1e9ff-efd2-f3a5-e053-2995a90adda72
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK22a4d2b3-daea-4d96-891f-4b98236294562
308460azithromycin 250 MG Oral TabletPSN22a4d2b3-daea-4d96-891f-4b98236294562
308460azithromycin 250 MG Oral TabletPSNf4c1e9ff-efd2-f3a5-e053-2995a90adda72
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf4c1e9ff-efd2-f3a5-e053-2995a90adda72
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN22a4d2b3-daea-4d96-891f-4b98236294562
308460azithromycin 250 MG Oral TabletSCDf4c1e9ff-efd2-f3a5-e053-2995a90adda72
308460azithromycin 250 MG Oral TabletSCD22a4d2b3-daea-4d96-891f-4b98236294562
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf4c1e9ff-efd2-f3a5-e053-2995a90adda72
749783azithromycin 250 MG Oral Tablet 6 Count PackSY22a4d2b3-daea-4d96-891f-4b98236294562
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK661ff7a6-6394-493d-a307-a1f607e5d1171
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK661ff7a6-6394-493d-a307-a1f607e5d1171
308460azithromycin 250 MG Oral TabletPSN661ff7a6-6394-493d-a307-a1f607e5d1171
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN661ff7a6-6394-493d-a307-a1f607e5d1171
248656azithromycin 500 MG Oral TabletPSN661ff7a6-6394-493d-a307-a1f607e5d1171
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN661ff7a6-6394-493d-a307-a1f607e5d1171
308460azithromycin 250 MG Oral TabletSCD661ff7a6-6394-493d-a307-a1f607e5d1171
248656azithromycin 500 MG Oral TabletSCD661ff7a6-6394-493d-a307-a1f607e5d1171
749783azithromycin 250 MG Oral Tablet 6 Count PackSY661ff7a6-6394-493d-a307-a1f607e5d1171
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY661ff7a6-6394-493d-a307-a1f607e5d1171
749780azithromycin 500 MG Oral Tablet 3 Count PackSY661ff7a6-6394-493d-a307-a1f607e5d1171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-8089-26007818089266 DOSE PACK in 1 CARTON (0781-8089-26) / 1 TABLET, FILM COATED in 1 DOSE PACK6 dose pack2019-02-140000-00-00NoNoCurrent
0781-8089-310078180893130 TABLET, FILM COATED in 1 BOTTLE (0781-8089-31) 2019-02-140000-00-00NoNoCurrent
0781-8089-69007818089695 BLISTER PACK in 1 CARTON (0781-8089-69) / 10 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2019-02-140000-00-00NoNoCurrent