FDA.reportPublic FDA data

Azithromycin

Product NDC
0781-8090
11-digit product format
007818090
Labeler code
0781
Product ID
0781-8090_a43a036c-9af9-4429-b0c0-731001003fea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065212
Marketing category
ANDA
Marketing start
2005-11-14
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 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 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
0781-8090-03Azithromycin3 in 1 DOSE PACKTABLET, FILM COATED34
0781-8090-03Azithromycin1 in 1 CARTONTABLET, FILM COATED14
0781-8090-31Azithromycin30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-8090AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]4Current NDC, Legacy NDC, 3 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
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK90605f94-93e1-43d1-8be7-830e816ac84f2
248656azithromycin 500 MG Oral TabletPSN90605f94-93e1-43d1-8be7-830e816ac84f2
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN90605f94-93e1-43d1-8be7-830e816ac84f2
248656azithromycin 500 MG Oral TabletSCD90605f94-93e1-43d1-8be7-830e816ac84f2
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY90605f94-93e1-43d1-8be7-830e816ac84f2
749780azithromycin 500 MG Oral Tablet 3 Count PackSY90605f94-93e1-43d1-8be7-830e816ac84f2
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
0781-8090-03007818090031 DOSE PACK in 1 CARTON (0781-8090-03) / 3 TABLET, FILM COATED in 1 DOSE PACK1 dose pack2019-02-140000-00-00NoNoCurrent
0781-8090-310078180903130 TABLET, FILM COATED in 1 BOTTLE (0781-8090-31) 2019-02-140000-00-00NoNoCurrent