Azithromycin

Product NDC
60687-753
11-digit product format
606870753
Labeler code
60687
Product ID
60687-753_37616a61-0547-5914-e063-6294a90a2cb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA065399
Marketing category
ANDA
Marketing start
2023-08-01
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

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
60687-753-11Azithromycin1 in 1 BLISTER PACKTABLET, FILM COATED14
60687-753-21Azithromycin30 in 1 CARTONTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-753AZITHROMYCIN DIHYDRATE TABLET [AMERICAN HEALTH PACKAGING]3Current NDC, 2 package rows20240524_6169e56c-10fb-448d-ab0f-14e54fcf2817.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSN6169e56c-10fb-448d-ab0f-14e54fcf28174
248656azithromycin 500 MG Oral TabletPSN6169e56c-10fb-448d-ab0f-14e54fcf28174
308460azithromycin 250 MG Oral TabletSCD6169e56c-10fb-448d-ab0f-14e54fcf28174
248656azithromycin 500 MG Oral TabletSCD6169e56c-10fb-448d-ab0f-14e54fcf28174
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY6169e56c-10fb-448d-ab0f-14e54fcf28174

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-753-11606870753111 in 1 BLISTER PACKHistorical
60687-753-216068707532130 BLISTER PACK in 1 CARTON (60687-753-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-753-11) 30 blister pack2023-08-01NoNoCurrent