FDA.reportPublic FDA data

Azithromycin

Product NDC
0093-7146
11-digit product format
000937146
Labeler code
0093
Product ID
0093-7146_663c9c2a-f6ce-43e4-b229-1f3328dd24a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA,
Application
ANDA065153
Marketing category
ANDA
Marketing start
2005-11-16
Marketing end
2020-03-31
Substance
AZITHROMYCIN MO
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antim
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7146-09EA - Each0093-7146a8bbe1ad-7eb9-4c5d-b08b-faee9e3d1e1712012-07-24
0093-7146-18EA - Each0093-7146ed1601dc-550b-49f5-926e-c3e674b6cae212012-07-24
0093-7146-56EA - Each0093-71463c882df6-bca3-4b05-9ad5-43b0c61bb36f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK7c960f3a-829f-452f-8206-ff9a72c014686
308460azithromycin 250 MG Oral TabletPSN7c960f3a-829f-452f-8206-ff9a72c014686
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN7c960f3a-829f-452f-8206-ff9a72c014686
308460azithromycin 250 MG Oral TabletSCD7c960f3a-829f-452f-8206-ff9a72c014686
749783azithromycin 250 MG Oral Tablet 6 Count PackSY7c960f3a-829f-452f-8206-ff9a72c014686
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK2bd73040-8aad-0bce-e054-00144ff8d46c2
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK42780e26-52d7-5914-e054-00144ff88e882
308460azithromycin 250 MG Oral TabletPSN2bd73040-8aad-0bce-e054-00144ff8d46c2
308460azithromycin 250 MG Oral TabletPSN42780e26-52d7-5914-e054-00144ff88e882
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN2bd73040-8aad-0bce-e054-00144ff8d46c2
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN42780e26-52d7-5914-e054-00144ff88e882
308460azithromycin 250 MG Oral TabletSCD2bd73040-8aad-0bce-e054-00144ff8d46c2
308460azithromycin 250 MG Oral TabletSCD42780e26-52d7-5914-e054-00144ff88e882
749783azithromycin 250 MG Oral Tablet 6 Count PackSY2bd73040-8aad-0bce-e054-00144ff8d46c2
749783azithromycin 250 MG Oral Tablet 6 Count PackSY42780e26-52d7-5914-e054-00144ff88e882
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK60bf8e22-284b-4dc0-9c03-694813cc89ac1
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK1e505c90-79e4-4267-83c4-2fbb93d75cc61
308460azithromycin 250 MG Oral TabletPSN1e505c90-79e4-4267-83c4-2fbb93d75cc61
308460azithromycin 250 MG Oral TabletPSN9a8d1dd4-c6e6-4fdc-b4a7-104b29d756e21
308460azithromycin 250 MG Oral TabletPSN60bf8e22-284b-4dc0-9c03-694813cc89ac1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN60bf8e22-284b-4dc0-9c03-694813cc89ac1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN1e505c90-79e4-4267-83c4-2fbb93d75cc61
308460azithromycin 250 MG Oral TabletSCD60bf8e22-284b-4dc0-9c03-694813cc89ac1
308460azithromycin 250 MG Oral TabletSCD1e505c90-79e4-4267-83c4-2fbb93d75cc61
308460azithromycin 250 MG Oral TabletSCD9a8d1dd4-c6e6-4fdc-b4a7-104b29d756e21
749783azithromycin 250 MG Oral Tablet 6 Count PackSY60bf8e22-284b-4dc0-9c03-694813cc89ac1
749783azithromycin 250 MG Oral Tablet 6 Count PackSY1e505c90-79e4-4267-83c4-2fbb93d75cc61