FDA.reportPublic FDA data

AZITHROMYCIN

Product NDC
21695-013
11-digit product format
216950013
Labeler code
21695
Product ID
21695-013_b9776e0b-8fc5-4d16-a5e2-482b806abb16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp.
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
21695-013-032019-09-24C16284748780-1934fe258-4ac1-48b1-e053-8cdaa90a720a6fadde9e-dab3-4d01-b3fb-795eef7eff2f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-013-03AZITHROMYCIN3 in 1 BOTTLETABLET, FILM COATED31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-013-03EA - Each21695-01389c123d9-27f9-44b9-b378-eeffbc599b5b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-013AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100212_6fadde9e-dab3-4d01-b3fb-795eef7eff2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
308460azithromycin 250 MG Oral TabletPSN6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
248656azithromycin 500 MG Oral TabletPSN6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
308460azithromycin 250 MG Oral TabletSCD6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
248656azithromycin 500 MG Oral TabletSCD6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
749783azithromycin 250 MG Oral Tablet 6 Count PackSY6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY6fadde9e-dab3-4d01-b3fb-795eef7eff2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-013-03216950013033 in 1 BOTTLEHistorical