AZITHROMYCIN

Product NDC
72189-015
11-digit product format
721890015
Labeler code
72189
Product ID
72189-015_2c4e8f12-2481-4a0d-e063-6394a90a58c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA207398
Marketing category
ANDA
Marketing start
2019-07-24
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

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
72189-015-02AZITHROMYCIN2 in 1 BOTTLETABLET, FILM COATED23
72189-015-03AZITHROMYCIN3 in 1 BOTTLETABLET, FILM COATED33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-015AZITHROMYCIN TABLET, FILM COATED [DIRECT_RX]3Current NDC, Legacy NDC, 2 package rows20250123_8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN8e6e11fb-eb9e-28ec-e053-2a95a90aa1a33
248656azithromycin 500 MG Oral TabletSCD8e6e11fb-eb9e-28ec-e053-2a95a90aa1a33
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY8e6e11fb-eb9e-28ec-e053-2a95a90aa1a33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-015-02721890015022 TABLET, FILM COATED in 1 BOTTLE (72189-015-02) 2019-07-240000-00-00NoNoCurrent
72189-015-03721890015033 TABLET, FILM COATED in 1 BOTTLE (72189-015-03) 2019-07-240000-00-00NoNoCurrent