Azithromycin

Product NDC
53217-161
11-digit product format
532170161
Labeler code
53217
Product ID
53217-161_e93d2a8a-9553-4318-a684-b30487bdf9f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065223
Marketing category
ANDA
Marketing start
2006-01-06
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-161-01Azithromycin1 in 1 CARTONTABLET, FILM COATED14
53217-161-01Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-161AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4Legacy NDC, 2 package rows20170313_77f12139-2e38-4298-b4f4-c24976cf0636.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK77f12139-2e38-4298-b4f4-c24976cf06364
308460azithromycin 250 MG Oral TabletPSN77f12139-2e38-4298-b4f4-c24976cf06364
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG Oral TabletPSN77f12139-2e38-4298-b4f4-c24976cf06364
308460azithromycin 250 MG Oral TabletSCD77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG Oral TabletSCD77f12139-2e38-4298-b4f4-c24976cf06364
749783azithromycin 250 MG Oral Tablet 6 Count PackSY77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY77f12139-2e38-4298-b4f4-c24976cf06364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-161-01532170161011 in 1 CARTONHistorical