AZITHROMYCIN

Product NDC
55648-961
11-digit product format
556480961
Labeler code
55648
Product ID
55648-961_e25928bc-ff72-4b62-b372-c50a7a3b9960
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA065404
Marketing category
ANDA
Marketing start
2008-02-11
Marketing end
0000-00-00
Substance
AZITHROMYCIN ANHYDROUS
Active strength
250 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-961-01AZITHROMYCIN30 in 1 BOTTLETABLET, FILM COATED301
55648-961-02AZITHROMYCIN10 in 1 BLISTER PACKTABLET, FILM COATED101
55648-961-02AZITHROMYCIN10 in 1 CARTONTABLET, FILM COATED101
55648-961-04AZITHROMYCIN6 in 1 BLISTER PACKTABLET, FILM COATED61
55648-961-05AZITHROMYCIN3 in 1 CARTONTABLET, FILM COATED31
55648-961-06AZITHROMYCIN5 in 1 CARTONTABLET, FILM COATED51
55648-961-06AZITHROMYCIN10 in 1 BLISTER PACKTABLET, FILM COATED101
55648-961-07AZITHROMYCIN500 in 1 BOTTLETABLET, FILM COATED5001
55648-961-08AZITHROMYCIN5 in 1 BOXTABLET, FILM COATED51
55648-961-08AZITHROMYCIN3500 in 1 BAGTABLET, FILM COATED35001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-961AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1Legacy NDC, 10 package rows20101122_a7bf9202-9590-49c8-bde1-78517e60850f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSNa7bf9202-9590-49c8-bde1-78517e60850f1
248656azithromycin 500 MG Oral TabletPSNa7bf9202-9590-49c8-bde1-78517e60850f1
308460azithromycin 250 MG Oral TabletSCDa7bf9202-9590-49c8-bde1-78517e60850f1
248656azithromycin 500 MG Oral TabletSCDa7bf9202-9590-49c8-bde1-78517e60850f1
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYa7bf9202-9590-49c8-bde1-78517e60850f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-961-015564809610130 in 1 BOTTLEHistorical
55648-961-025564809610210 in 1 BLISTER PACKHistorical
55648-961-04556480961046 in 1 BLISTER PACKHistorical
55648-961-05556480961053 in 1 CARTONHistorical
55648-961-06556480961065 in 1 CARTONHistorical
55648-961-0755648096107500 in 1 BOTTLEHistorical
55648-961-08556480961085 in 1 BOXHistorical