azithromycin

Product NDC
59762-3080
11-digit product format
597623080
Labeler code
59762
Product ID
59762-3080_0d8b9de2-23e7-41e1-8a6a-7ed668b9e003
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA050730
Marketing category
NDA
Marketing start
1996-06-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
600 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-3080-1EA - Each59762-3080e892bac6-5187-48b9-a5db-7dbeb8bdf4dd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN DIHYDRATEACTIVE INGREDIENT5FD1131I7SAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SUCROSEINACTIVE INGREDIENTC151H8M554AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-3080AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]36Legacy NDC20250206_d470695c-c0d7-4361-8783-45f58a932ac4.zip