Azithromycin

Product NDC
50111-787
11-digit product format
501110787
Labeler code
50111
Product ID
50111-787_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
ANDA065225
Marketing category
ANDA
Marketing start
2006-01-06
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 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 MONOHYDRATE250 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
50111-787-10Azithromycin30 in 1 BOTTLETABLET, FILM COATED3022
50111-787-51Azithromycin1 in 1 CARTONTABLET, FILM COATED122
50111-787-51Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED622
50111-787-66Azithromycin3 in 1 PACKAGETABLET, FILM COATED322
50111-787-66Azithromycin1 in 1 CARTONTABLET, FILM COATED122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-787-10EA - Each50111-787f2bf0176-f48a-4e90-b10e-f6fb2fda516b12017-10-13
50111-787-51EA - Each50111-7878e64b23d-999c-4945-8291-00bd18d54d6312013-02-13
50111-787-66EA - Each50111-78759338e67-5e55-49e4-8ac2-d7f759ede6c912012-07-24

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 MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
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 [MEDSOURCE PHARMACEUTICALS]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-787AZITHROMYCIN 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
308460azithromycin 250 MG Oral TabletPSN333ffe63-aaeb-4dff-b595-1c11209189a617
308460azithromycin 250 MG Oral TabletSCD333ffe63-aaeb-4dff-b595-1c11209189a617
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
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK884d8dfb-980a-4bf9-aacd-7eba6373315b5
308460azithromycin 250 MG Oral TabletPSNcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
308460azithromycin 250 MG Oral TabletPSN884d8dfb-980a-4bf9-aacd-7eba6373315b5
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN884d8dfb-980a-4bf9-aacd-7eba6373315b5
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
308460azithromycin 250 MG Oral TabletSCD884d8dfb-980a-4bf9-aacd-7eba6373315b5
248656azithromycin 500 MG Oral TabletSCDcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749783azithromycin 250 MG Oral Tablet 6 Count PackSY884d8dfb-980a-4bf9-aacd-7eba6373315b5
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) } PackGPCK84aa116a-4aae-4e91-801f-1c5ced73ddce4
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK77f12139-2e38-4298-b4f4-c24976cf06364
308460azithromycin 250 MG Oral TabletPSN84aa116a-4aae-4e91-801f-1c5ced73ddce4
308460azithromycin 250 MG Oral TabletPSN77f12139-2e38-4298-b4f4-c24976cf06364
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN84aa116a-4aae-4e91-801f-1c5ced73ddce4
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 TabletSCD84aa116a-4aae-4e91-801f-1c5ced73ddce4
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 PackSY84aa116a-4aae-4e91-801f-1c5ced73ddce4
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) } PackGPCKf175496a-4ad3-ce0d-e053-2a95a90a66133
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf454c421-ebbe-4a58-b9fa-000dab90a6e03
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK5f9e13f5-69ee-4220-90d9-31fa8660d8803
308460azithromycin 250 MG Oral TabletPSNf454c421-ebbe-4a58-b9fa-000dab90a6e03
308460azithromycin 250 MG Oral TabletPSNf175496a-4ad3-ce0d-e053-2a95a90a66133
308460azithromycin 250 MG Oral TabletPSN5f9e13f5-69ee-4220-90d9-31fa8660d8803
308460azithromycin 250 MG Oral TabletPSN9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf175496a-4ad3-ce0d-e053-2a95a90a66133
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN5f9e13f5-69ee-4220-90d9-31fa8660d8803
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf454c421-ebbe-4a58-b9fa-000dab90a6e03
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 TabletSCD5f9e13f5-69ee-4220-90d9-31fa8660d8803
308460azithromycin 250 MG Oral TabletSCD9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
308460azithromycin 250 MG Oral TabletSCDf454c421-ebbe-4a58-b9fa-000dab90a6e03
308460azithromycin 250 MG Oral TabletSCDf175496a-4ad3-ce0d-e053-2a95a90a66133
248656azithromycin 500 MG Oral TabletSCD9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf454c421-ebbe-4a58-b9fa-000dab90a6e03
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf175496a-4ad3-ce0d-e053-2a95a90a66133
749783azithromycin 250 MG Oral Tablet 6 Count PackSY9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783azithromycin 250 MG Oral Tablet 6 Count PackSY5f9e13f5-69ee-4220-90d9-31fa8660d8803
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749780azithromycin 500 MG Oral Tablet 3 Count PackSY9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
308460azithromycin 250 MG Oral TabletPSNc6c94568-1e3c-494a-893b-e84f019cc5fc2
308460azithromycin 250 MG Oral TabletPSNbb23de1f-6c42-4b36-a840-a377f50826832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-787-105011107871030 TABLET, FILM COATED in 1 BOTTLE (50111-787-10) 2006-01-060000-00-00NoNoCurrent
50111-787-51501110787511 BLISTER PACK in 1 CARTON (50111-787-51) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2006-01-060000-00-00NoNoCurrent
50111-787-66501110787663 CARTON in 1 PACKAGE (50111-787-66) / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK3 carton2006-01-060000-00-00NoNoCurrent