azithromycin

Product NDC
55154-3374
11-digit product format
551543374
Labeler code
55154
Product ID
55154-3374_aec6220d-591c-4fb7-98a5-07cdd3a8eb28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA065398
Marketing category
ANDA
Marketing start
2024-07-02
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
Rxcui308460

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
55154-3374-0azithromycin10 in 1 BAGTABLET, FILM COATED103
55154-3374-0azithromycin1 in 1 BLISTER PACKTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3374AZITHROMYCIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]2Current NDC, 2 package rows20250529_ea128124-8712-4998-be46-47d43ef127d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSNea128124-8712-4998-be46-47d43ef127d43
308460azithromycin 250 MG Oral TabletSCDea128124-8712-4998-be46-47d43ef127d43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-3374-05515433740010 BLISTER PACK in 1 BAG (55154-3374-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2024-07-02NoNoCurrent