FDA.reportPublic FDA data

AZITHROMYCIN

Product NDC
55045-3693
11-digit product format
550453693
Labeler code
55045
Product ID
55045-3693_beed0095-b4a2-4a71-b484-f27325bc899a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA065405
Marketing category
ANDA
Marketing start
2008-02-11
Marketing end
0000-00-00
Substance
AZITHROMYCIN ANHYDROUS
Active strength
500 mg/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

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
55045-3693-12019-10-29C16284748780-1960f7f55-c692-8e05-e053-dbdaa90a074a8f0b9785-1b5c-41f0-a6f2-80088aab18b1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55045-3693-1AZITHROMYCIN3 in 1 BLISTER PACKTABLET, FILM COATED31

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-3693AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20110923_8f0b9785-1b5c-41f0-a6f2-80088aab18b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK8f0b9785-1b5c-41f0-a6f2-80088aab18b11
248656azithromycin 500 MG Oral TabletPSN8f0b9785-1b5c-41f0-a6f2-80088aab18b11
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN8f0b9785-1b5c-41f0-a6f2-80088aab18b11
248656azithromycin 500 MG Oral TabletSCD8f0b9785-1b5c-41f0-a6f2-80088aab18b11
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY8f0b9785-1b5c-41f0-a6f2-80088aab18b11
749780azithromycin 500 MG Oral Tablet 3 Count PackSY8f0b9785-1b5c-41f0-a6f2-80088aab18b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55045-3693-1550453693013 in 1 BLISTER PACKHistorical