FDA.reportPublic FDA data

Azithromycin

Product NDC
62980-964
11-digit product format
629800964
Labeler code
62980
Product ID
62980-964_abb76e1d-a0c6-407b-b70c-1d5da87f4902
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Vivimed Labs Limited
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 [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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
62980-964-012020-01-31C16284748780-19d75b9d0-8d9d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
62980-964-022020-01-31C16284748780-19d75b9d0-8d9d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
62980-964-052020-01-31C16284748780-19d75b9d0-8d9d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
62980-964-072020-01-31C16284748780-19d75b9d0-8d9d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
62980-964-082020-01-31C16284748780-19d75b9d0-8d9d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62980-964-01Azithromycin30 in 1 BOTTLETABLET, FILM COATED302
62980-964-02Azithromycin10 in 1 CARTONTABLET, FILM COATED102
62980-964-03Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED32
62980-964-05Azithromycin3 in 1 CARTONTABLET, FILM COATED32
62980-964-07Azithromycin500 in 1 BOTTLETABLET, FILM COATED5002
62980-964-08Azithromycin1700 in 1 BAGTABLET, FILM COATED17002
62980-964-09Azithromycin10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TAZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62980-964AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]2Legacy NDC, 7 package rows20170926_f6edd3c1-4455-4f05-b554-49d59d442270.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKf6edd3c1-4455-4f05-b554-49d59d4422702
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf6edd3c1-4455-4f05-b554-49d59d4422702
308460azithromycin 250 MG Oral TabletPSNf6edd3c1-4455-4f05-b554-49d59d4422702
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf6edd3c1-4455-4f05-b554-49d59d4422702
248656azithromycin 500 MG Oral TabletPSNf6edd3c1-4455-4f05-b554-49d59d4422702
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNf6edd3c1-4455-4f05-b554-49d59d4422702
308460azithromycin 250 MG Oral TabletSCDf6edd3c1-4455-4f05-b554-49d59d4422702
248656azithromycin 500 MG Oral TabletSCDf6edd3c1-4455-4f05-b554-49d59d4422702
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf6edd3c1-4455-4f05-b554-49d59d4422702
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYf6edd3c1-4455-4f05-b554-49d59d4422702
749780azithromycin 500 MG Oral Tablet 3 Count PackSYf6edd3c1-4455-4f05-b554-49d59d4422702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62980-964-016298009640130 in 1 BOTTLEHistorical
62980-964-026298009640210 in 1 CARTONHistorical
62980-964-03629800964033 in 1 BLISTER PACKHistorical
62980-964-05629800964053 in 1 CARTONHistorical
62980-964-0762980096407500 in 1 BOTTLEHistorical
62980-964-08629800964081700 in 1 BAGHistorical
62980-964-096298009640910 in 1 BLISTER PACKHistorical