FDA.reportPublic FDA data

Azithromycin

Product NDC
50111-788
11-digit product format
501110788
Labeler code
50111
Product ID
50111-788_96661456-78d1-48f2-bcd9-ceb3a8437387
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065223
Marketing category
ANDA
Marketing start
2006-01-06
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN MONOHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJTE4MNN1MD
Rxcui248656, 308460, 749780, 749783

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50111-788-10Azithromycin30 in 1 BOTTLETABLET, FILM COATED3022
50111-788-55Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED322
50111-788-55Azithromycin1 in 1 CARTONTABLET, FILM COATED122
50111-788-67Azithromycin3 in 1 PACKAGETABLET, FILM COATED322
50111-788-67Azithromycin1 in 1 CARTONTABLET, FILM COATED122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-788-10EA - Each50111-78834ba7254-d45a-4b22-acca-b09320ec98e212017-05-03
50111-788-52EA - Each50111-7887407ce89-89df-40cb-9adb-e7ea1d93987c12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAZITHROMYCIN TABLET, FILM COATED [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-788AZITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]21Current NDC, Legacy NDC, 5 package rows20230807_f6a52c0b-45db-422e-8c22-e867a11b4439.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKf6a52c0b-45db-422e-8c22-e867a11b443922
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf6a52c0b-45db-422e-8c22-e867a11b443922
308460azithromycin 250 MG Oral TabletPSNf6a52c0b-45db-422e-8c22-e867a11b443922
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf6a52c0b-45db-422e-8c22-e867a11b443922
248656azithromycin 500 MG Oral TabletPSNf6a52c0b-45db-422e-8c22-e867a11b443922
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNf6a52c0b-45db-422e-8c22-e867a11b443922
308460azithromycin 250 MG Oral TabletSCDf6a52c0b-45db-422e-8c22-e867a11b443922
248656azithromycin 500 MG Oral TabletSCDf6a52c0b-45db-422e-8c22-e867a11b443922
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf6a52c0b-45db-422e-8c22-e867a11b443922
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYf6a52c0b-45db-422e-8c22-e867a11b443922
749780azithromycin 500 MG Oral Tablet 3 Count PackSYf6a52c0b-45db-422e-8c22-e867a11b443922
248656azithromycin 500 MG Oral TabletPSN943b9246-7733-44b1-875c-91d2ade78ac417
248656azithromycin 500 MG Oral TabletSCD943b9246-7733-44b1-875c-91d2ade78ac417
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY943b9246-7733-44b1-875c-91d2ade78ac417
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
308460azithromycin 250 MG Oral TabletPSN7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
248656azithromycin 500 MG Oral TabletPSN7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
308460azithromycin 250 MG Oral TabletSCD7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
248656azithromycin 500 MG Oral TabletSCD7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
749783azithromycin 250 MG Oral Tablet 6 Count PackSY7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
308460azithromycin 250 MG Oral TabletPSN2c8c977f-6acf-40f9-8a5b-253eb0188ed27
248656azithromycin 500 MG Oral TabletPSN2c8c977f-6acf-40f9-8a5b-253eb0188ed27
308460azithromycin 250 MG Oral TabletSCD2c8c977f-6acf-40f9-8a5b-253eb0188ed27
248656azithromycin 500 MG Oral TabletSCD2c8c977f-6acf-40f9-8a5b-253eb0188ed27
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY2c8c977f-6acf-40f9-8a5b-253eb0188ed27
248656azithromycin 500 MG Oral TabletPSN334fc377-ab51-418e-ad4b-2a243718095e6
248656azithromycin 500 MG Oral TabletSCD334fc377-ab51-418e-ad4b-2a243718095e6
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY334fc377-ab51-418e-ad4b-2a243718095e6
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
308460azithromycin 250 MG Oral TabletPSNcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
248656azithromycin 500 MG Oral TabletPSNcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
308460azithromycin 250 MG Oral TabletSCDcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
248656azithromycin 500 MG Oral TabletSCDcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749780azithromycin 500 MG Oral Tablet 3 Count PackSYcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK77f12139-2e38-4298-b4f4-c24976cf06364
308460azithromycin 250 MG Oral TabletPSN77f12139-2e38-4298-b4f4-c24976cf06364
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG Oral TabletPSN77f12139-2e38-4298-b4f4-c24976cf06364
308460azithromycin 250 MG Oral TabletSCD77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG Oral TabletSCD77f12139-2e38-4298-b4f4-c24976cf06364
749783azithromycin 250 MG Oral Tablet 6 Count PackSY77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY77f12139-2e38-4298-b4f4-c24976cf06364
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
308460azithromycin 250 MG Oral TabletPSN9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
248656azithromycin 500 MG Oral TabletPSN9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
308460azithromycin 250 MG Oral TabletSCD9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
248656azithromycin 500 MG Oral TabletSCD9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783azithromycin 250 MG Oral Tablet 6 Count PackSY9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749780azithromycin 500 MG Oral Tablet 3 Count PackSY9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
248656azithromycin 500 MG Oral TabletPSNba57ff26-cd02-4f57-ac92-b613d245a4ea2
248656azithromycin 500 MG Oral TabletPSN397471e5-76e2-462c-af30-bcc54fe002662
248656azithromycin 500 MG Oral TabletSCDba57ff26-cd02-4f57-ac92-b613d245a4ea2
248656azithromycin 500 MG Oral TabletSCD397471e5-76e2-462c-af30-bcc54fe002662
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYba57ff26-cd02-4f57-ac92-b613d245a4ea2
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY397471e5-76e2-462c-af30-bcc54fe002662
248656azithromycin 500 MG Oral TabletPSN8c2d65e1-7fa4-49ee-aa12-0322fc303c281
248656azithromycin 500 MG Oral TabletSCD8c2d65e1-7fa4-49ee-aa12-0322fc303c281
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY8c2d65e1-7fa4-49ee-aa12-0322fc303c281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-788-105011107881030 TABLET, FILM COATED in 1 BOTTLE (50111-788-10) 2006-01-060000-00-00NoNoCurrent
50111-788-55501110788551 BLISTER PACK in 1 CARTON (50111-788-55) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2014-02-180000-00-00NoNoCurrent
50111-788-67501110788673 CARTON in 1 PACKAGE (50111-788-67) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK3 carton2006-01-060000-00-00NoNoCurrent