AZITHROMYCIN

Product NDC
55648-962
11-digit product format
556480962
Labeler code
55648
Product ID
55648-962_a83b5bd6-9e8e-4d1b-abc2-d27f28223598
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA065302
Marketing category
ANDA
Marketing start
2008-02-11
Marketing end
0000-00-00
Substance
AZITHROMYCIN ANHYDROUS
Active strength
600 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
55648-962-012019-10-29C16284748780-1960f7f55-d529-8e05-e053-dbdaa90a074aAzithromycin Tablets 600 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-962-01AZITHROMYCIN30 in 1 BOTTLETABLET, FILM COATED301

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
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-962AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]1Legacy NDC, 1 package rows20101126_fb0ff563-b87b-439b-885d-49572d3c0c12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204844azithromycin 600 MG Oral TabletPSNfb0ff563-b87b-439b-885d-49572d3c0c121
204844azithromycin 600 MG Oral TabletSCDfb0ff563-b87b-439b-885d-49572d3c0c121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-962-015564809620130 in 1 BOTTLEHistorical