FDA.reportPublic FDA data

azithromycin

Product NDC
0904-7350
11-digit product format
009047350
Labeler code
0904
Product ID
0904-7350_7cae275e-abb8-4fad-af20-fa3fdbf095e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA065398
Marketing category
ANDA
Marketing start
2023-05-01
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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 DIHYDRATE250 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
0904-7350-06azithromycin1 in 1 BLISTER PACKTABLET, FILM COATED15
0904-7350-06azithromycin50 in 1 CARTONTABLET, FILM COATED505
0904-7350-61azithromycin1 in 1 BLISTER PACKTABLET, FILM COATED15
0904-7350-61azithromycin100 in 1 CARTONTABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7350-06EA - Each0904-73504f180e1b-2663-4ced-a61a-6025f56d11b712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7350AZITHROMYCIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4Current NDC, 4 package rows20250514_814abe38-da4a-48af-bf4b-2ce04a5aabd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSN814abe38-da4a-48af-bf4b-2ce04a5aabd15
248656azithromycin 500 MG Oral TabletPSN814abe38-da4a-48af-bf4b-2ce04a5aabd15
308460azithromycin 250 MG Oral TabletSCD814abe38-da4a-48af-bf4b-2ce04a5aabd15
248656azithromycin 500 MG Oral TabletSCD814abe38-da4a-48af-bf4b-2ce04a5aabd15
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY814abe38-da4a-48af-bf4b-2ce04a5aabd15
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
0904-7350-060090473500650 BLISTER PACK in 1 CARTON (0904-7350-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2023-05-01NoNoCurrent
0904-7350-6100904735061100 BLISTER PACK in 1 CARTON (0904-7350-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2023-05-01NoNoCurrent