azithromycin

Product NDC
68258-3051
11-digit product format
682583051
Labeler code
68258
Product ID
68258-3051_3d465feb-afd8-4252-9c9e-3a4be10a6ebd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA050693
Marketing category
NDA
Marketing start
1999-02-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN
Active strength
1 g/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-3051-12019-11-13C16284748780-197449f38-b540-f6ea-e053-dbdaa90aa703AZITHROMYCIN azithromycin tablets and azithromycin for oral suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3051-1azithromycin10 in 1 BOXPOWDER, FOR SUSPENSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68258-3051-1EA - Each68258-3051733f1893-d4ed-4afe-92a4-a8e24f79732312013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
azithromycinACTIVE INGREDIENTF94OW58Y8VAZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
azithromycinACTIVE MOIETYF94OW58Y8VAZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
sodium phosphate, tribasic anhydrousINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
sucroseINACTIVE INGREDIENTC151H8M554AZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3051AZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20111004_53e2801a-323d-448e-8278-92d672904b0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861416azithromycin 1 GM Powder for Oral SuspensionPSN53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1000 MG Powder for Oral SuspensionSCD53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1 GM Powder for Oral SuspensionSY53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1000 MG Powder for Oral SuspensionSY53e2801a-323d-448e-8278-92d672904b0f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-3051-16825830510110 in 1 BOXHistorical