FDA.reportPublic FDA data

Azithromycin

Product NDC
85766-077
11-digit product format
857660077
Labeler code
85766
Product ID
85766-077_50318293-408d-c148-e063-6394a90a7168
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA065223
Marketing category
ANDA
Marketing start
2006-01-06
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 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 MONOHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJTE4MNN1MD
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
85766-077-03Azithromycin1 in 1 CARTONTABLET, FILM COATED12
85766-077-03Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED32
85766-077-09Azithromycin1 in 1 CARTONTABLET, FILM COATED12
85766-077-09Azithromycin3 in 1 PACKAGETABLET, FILM COATED32
85766-077-30Azithromycin30 in 1 BOTTLETABLET, FILM COATED302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN397471e5-76e2-462c-af30-bcc54fe002662
248656azithromycin 500 MG Oral TabletSCD397471e5-76e2-462c-af30-bcc54fe002662
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY397471e5-76e2-462c-af30-bcc54fe002662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-077-03857660077031 BLISTER PACK in 1 CARTON (85766-077-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-10-10NoNoHistorical
85766-077-09857660077093 CARTON in 1 PACKAGE (85766-077-09) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK3 carton2025-10-10NoNoHistorical
85766-077-308576600773030 TABLET, FILM COATED in 1 BOTTLE (85766-077-30) 2025-10-10NoNoHistorical