Azithromycin

Product NDC
71205-674
11-digit product format
712050674
Labeler code
71205
Product ID
71205-674_69477c94-fdae-4d10-b4e0-2f3c566f2eba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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, 749780

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
71205-674-03Azithromycin3 in 1 DOSE PACKTABLET, FILM COATED32
71205-674-03Azithromycin1 in 1 CARTONTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-674-03EA - Each71205-6748a243eb7-ebcd-42dd-aa01-1ec4725d2c0812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-674AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 2 package rows20241031_90605f94-93e1-43d1-8be7-830e816ac84f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-674-03712050674031 DOSE PACK in 1 CARTON (71205-674-03) / 3 TABLET, FILM COATED in 1 DOSE PACK1 dose pack2022-07-070000-00-00NoNoCurrent