azithromycin

Product NDC
59762-3060
11-digit product format
597623060
Labeler code
59762
Product ID
59762-3060_e65a0723-d06f-49f1-8af5-88f67338a90f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA050711
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1996-07-18
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-3060-1EA - Each59762-3060d2fccedb-807e-408b-8219-fc403e80891f12012-07-24
59762-3060-2EA - Each59762-3060d9904624-dbe2-4d4d-911d-1641e9303ea012012-07-24
59762-3060-3EA - Each59762-30609a90fb8c-d903-4a74-8abf-eb86177f98fa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN DIHYDRATEACTIVE INGREDIENT5FD1131I7SAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
SUCROSEINACTIVE INGREDIENTC151H8M554AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-3060AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]41Legacy NDC20250416_f5b6daad-b5a9-462d-8e10-db22a7af1c72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN2dc92556-ca5a-608c-e054-00144ff88e882
308460azithromycin 250 MG Oral TabletPSN2dc92556-ca5a-608c-e054-00144ff88e882
308460azithromycin 250 MG Oral TabletSCD2dc92556-ca5a-608c-e054-00144ff88e882
141963azithromycin 40 MG/ML Oral SuspensionSCD2dc92556-ca5a-608c-e054-00144ff88e882
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY2dc92556-ca5a-608c-e054-00144ff88e882
141963azithromycin 200 MG per 5 ML Oral SuspensionSY2dc92556-ca5a-608c-e054-00144ff88e882
141963azithromycin 600 MG per 15 ML Oral SuspensionSY2dc92556-ca5a-608c-e054-00144ff88e882
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKfa72135d-7307-4c21-bc56-1068f9b057b51
308460azithromycin 250 MG Oral TabletPSN794a2a15-24c1-430f-8821-643164c26dbf1
308460azithromycin 250 MG Oral TabletPSNfa72135d-7307-4c21-bc56-1068f9b057b51
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNfa72135d-7307-4c21-bc56-1068f9b057b51
308460azithromycin 250 MG Oral TabletSCD794a2a15-24c1-430f-8821-643164c26dbf1
308460azithromycin 250 MG Oral TabletSCDfa72135d-7307-4c21-bc56-1068f9b057b51
749783azithromycin 250 MG Oral Tablet 6 Count PackSYfa72135d-7307-4c21-bc56-1068f9b057b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-3060-1597623060013 BLISTER PACK in 1 BOX (59762-3060-1) > 6 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack1996-07-180000-00-00NoNoCurrent