azithromycin

Product NDC
59762-3110
11-digit product format
597623110
Labeler code
59762
Product ID
59762-3110_86aefdeb-2e61-4763-8593-fce5f69f5564
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Greenstone LLC
Application
NDA050710
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1995-10-19
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
100 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59762-3110-12024-07-30C16284748780-11030e365-641a-111a-e063-dadaa90a10e2f5b6daad-b5a9-462d-8e10-db22a7af1c72
59762-3110-12024-01-30C16284748780-11030e365-641a-111a-e063-dadaa90a10e2f5b6daad-b5a9-462d-8e10-db22a7af1c72

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-3110-1ML - Milliliter59762-31102cf9b0ba-cb2c-4cad-ab6e-d54396b4e43b12012-07-24

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
AZITHROMYCINACTIVE INGREDIENTF94OW58Y8VAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PHOSPHATE, TRIBASIC ANHYDROUSINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-3110AZITHROMYCIN 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
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN966c8f58-fde1-4af0-964b-c0bddbb05b362
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN966c8f58-fde1-4af0-964b-c0bddbb05b362
308459azithromycin 20 MG/ML Oral SuspensionSCD966c8f58-fde1-4af0-964b-c0bddbb05b362
141963azithromycin 40 MG/ML Oral SuspensionSCD966c8f58-fde1-4af0-964b-c0bddbb05b362
308459azithromycin 100 MG per 5 ML Oral SuspensionSY966c8f58-fde1-4af0-964b-c0bddbb05b362
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY966c8f58-fde1-4af0-964b-c0bddbb05b362
141963azithromycin 200 MG per 5 ML Oral SuspensionSY966c8f58-fde1-4af0-964b-c0bddbb05b362
141963azithromycin 600 MG per 15 ML Oral SuspensionSY966c8f58-fde1-4af0-964b-c0bddbb05b362
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN84a179f2-08a3-47a4-81cb-aea0abef55471
308459azithromycin 20 MG/ML Oral SuspensionSCD84a179f2-08a3-47a4-81cb-aea0abef55471
308459azithromycin 100 MG per 5 ML Oral SuspensionSY84a179f2-08a3-47a4-81cb-aea0abef55471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-3110-1597623110011 BOTTLE in 1 CARTON (59762-3110-1) > 15 mL in 1 BOTTLE1 bottle1995-10-190000-00-00NoNoCurrent