FDA.reportPublic FDA data

Azithromycin

Product NDC
64679-964
11-digit product format
646790964
Labeler code
64679
Product ID
64679-964_d2a1950b-4358-ad27-e053-2a95a90a7f92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt USA LLC.
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
No
Listing certified through
2022-12-31
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
64679-964-012024-11-14C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-964-022024-11-14C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-964-052024-11-14C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-964-072024-11-14C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-964-082024-11-14C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-964-012023-01-30C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-964-022023-01-30C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-964-052023-01-30C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-964-072023-01-30C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-964-082023-01-30C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-964-01EA - Each64679-9643d29e384-297e-4c81-be79-723f46323f6212012-07-24
64679-964-02EA - Each64679-9642e420ffd-6ae9-4527-91c2-44b336f5a25d12022-04-06
64679-964-03EA - Each64679-964c823e48a-73ff-4315-8ca1-8427740b7d6b12012-07-24
64679-964-05EA - Each64679-964ac94c3db-9f4c-4aa5-b32a-d35d31644eb712012-07-24
64679-964-07EA - Each64679-964fbcf7ed8-5822-4476-beb0-90fe8fbb4c3812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN962bd404-62b5-4a7f-8ad4-45284228ac0f5
248656azithromycin 500 MG Oral TabletSCD962bd404-62b5-4a7f-8ad4-45284228ac0f5
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY962bd404-62b5-4a7f-8ad4-45284228ac0f5
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK1846ad3c-26ed-4c6f-8dae-a0f3502df3e01
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK8f0b9785-1b5c-41f0-a6f2-80088aab18b11
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK32ae8f5a-ea78-4e64-a58a-856ed8cf4f781
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKeeea2ed3-ae33-4e88-abdf-dfcf85582d461
308460azithromycin 250 MG Oral TabletPSN6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
308460azithromycin 250 MG Oral TabletPSNeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
248656azithromycin 500 MG Oral TabletPSN32ae8f5a-ea78-4e64-a58a-856ed8cf4f781
248656azithromycin 500 MG Oral TabletPSNbbe9aca5-77b3-411f-863d-571de9a9a4b61
248656azithromycin 500 MG Oral TabletPSN6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
248656azithromycin 500 MG Oral TabletPSN8f0b9785-1b5c-41f0-a6f2-80088aab18b11
248656azithromycin 500 MG Oral TabletPSNeeea2ed3-ae33-4e88-abdf-dfcf85582d461
248656azithromycin 500 MG Oral TabletPSN1846ad3c-26ed-4c6f-8dae-a0f3502df3e01
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN8f0b9785-1b5c-41f0-a6f2-80088aab18b11
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN1846ad3c-26ed-4c6f-8dae-a0f3502df3e01
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN32ae8f5a-ea78-4e64-a58a-856ed8cf4f781
308460azithromycin 250 MG Oral TabletSCD6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
308460azithromycin 250 MG Oral TabletSCDeeea2ed3-ae33-4e88-abdf-dfcf85582d461
248656azithromycin 500 MG Oral TabletSCD8f0b9785-1b5c-41f0-a6f2-80088aab18b11
248656azithromycin 500 MG Oral TabletSCD6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
248656azithromycin 500 MG Oral TabletSCD1846ad3c-26ed-4c6f-8dae-a0f3502df3e01
248656azithromycin 500 MG Oral TabletSCD32ae8f5a-ea78-4e64-a58a-856ed8cf4f781
248656azithromycin 500 MG Oral TabletSCDbbe9aca5-77b3-411f-863d-571de9a9a4b61
248656azithromycin 500 MG Oral TabletSCDeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749783azithromycin 250 MG Oral Tablet 6 Count PackSY6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
749783azithromycin 250 MG Oral Tablet 6 Count PackSYeeea2ed3-ae33-4e88-abdf-dfcf85582d461
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY1846ad3c-26ed-4c6f-8dae-a0f3502df3e01
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYeeea2ed3-ae33-4e88-abdf-dfcf85582d461
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYbbe9aca5-77b3-411f-863d-571de9a9a4b61
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY8f0b9785-1b5c-41f0-a6f2-80088aab18b11
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY32ae8f5a-ea78-4e64-a58a-856ed8cf4f781
749780azithromycin 500 MG Oral Tablet 3 Count PackSY1846ad3c-26ed-4c6f-8dae-a0f3502df3e01
749780azithromycin 500 MG Oral Tablet 3 Count PackSY8f0b9785-1b5c-41f0-a6f2-80088aab18b11
749780azithromycin 500 MG Oral Tablet 3 Count PackSYeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749780azithromycin 500 MG Oral Tablet 3 Count PackSY32ae8f5a-ea78-4e64-a58a-856ed8cf4f781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-964-016467909640130 TABLET, FILM COATED in 1 BOTTLE (64679-964-01) 2015-07-280000-00-00NoNoCurrent
64679-964-026467909640210 BLISTER PACK in 1 CARTON (64679-964-02) > 10 TABLET, FILM COATED in 1 BLISTER PACK (64679-964-09) 10 blister pack2015-07-280000-00-00NoNoCurrent
64679-964-05646790964053 BLISTER PACK in 1 CARTON (64679-964-05) > 3 TABLET, FILM COATED in 1 BLISTER PACK (64679-964-03) 3 blister pack2015-07-280000-00-00NoNoCurrent
64679-964-0764679096407500 TABLET, FILM COATED in 1 BOTTLE (64679-964-07) 2015-07-280000-00-00NoNoCurrent
64679-964-08646790964081700 TABLET, FILM COATED in 1 BAG (64679-964-08) 2015-07-280000-00-00NoNoCurrent