Azithromycin

Product NDC
67296-1945
11-digit product format
672961945
Labeler code
67296
Product ID
67296-1945_46e92ad2-2f3f-cdb3-e063-6294a90a983a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Redpharm Drug
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
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
67296-1945-5Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED33
67296-1945-5Azithromycin5 in 1 CARTONTABLET, FILM COATED53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1945AZITHROMYCIN TABLET, FILM COATED [REDPHARM DRUG]1Current NDC, 2 package rows20250309_2fd25741-f014-3999-e063-6394a90acdd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK2fd25741-f014-3999-e063-6394a90acdd03
248656azithromycin 500 MG Oral TabletPSN2fd25741-f014-3999-e063-6394a90acdd03
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN2fd25741-f014-3999-e063-6394a90acdd03
248656azithromycin 500 MG Oral TabletSCD2fd25741-f014-3999-e063-6394a90acdd03
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY2fd25741-f014-3999-e063-6394a90acdd03
749780azithromycin 500 MG Oral Tablet 3 Count PackSY2fd25741-f014-3999-e063-6394a90acdd03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-1945-5672961945055 BLISTER PACK in 1 CARTON (67296-1945-5) / 3 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2018-07-05NoNoCurrent