Azithromycin

Product NDC
68788-9977
11-digit product format
687889977
Labeler code
68788
Product ID
68788-9977_80d6727a-a499-4723-80ca-994eedb6fd9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065225
Marketing category
ANDA
Marketing start
2015-04-16
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9977DDiscontinued by firm2026-08-03
excluded packagepackage68788-997768788-9977-6DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9977-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9977-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9977-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9977-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9977-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9977-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9977-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9977-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9977-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9977-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9977-6367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9977-6557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065225-001AZITHROMYCINAZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A065225-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065225-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065225-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065225-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065225-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065225-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065225-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065225-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065225-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065225-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065225-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065225-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065225-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065225-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065225-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065225-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065225-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065225-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065225-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065225-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065225-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065225-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065225-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065225-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065225-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065225-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065225-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065225-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065225-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065225-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065225-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065225-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065225-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065225-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065225-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065225-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065225-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065225-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065225-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065225-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065225-001AB1cb3db0bc1861…

DailyMed Socrata Ingredients#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINREMEDYREPACK INC.333ffe63-aaeb-4dff-b595-1c11209189a62026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCINSportpharm LLC5f9e13f5-69ee-4220-90d9-31fa8660d8802026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCINAdvanced Rx Pharmacy of Tennessee, LLCf175496a-4ad3-ce0d-e053-2a95a90a66132024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCINAsclemed USA, Inc.9c44af6d-8a9a-cb4c-e053-2a95a90afdac2023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCINTeva Pharmaceuticals USA, Inc.f6a52c0b-45db-422e-8c22-e867a11b44392023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCIN MONOHYDRATEPharmPak, Inc.ba57ff26-cd02-4f57-ac92-b613d245a4ea2022-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCINProficient Rx LP7e7c2f49-449c-4ba2-98ae-0ff0c040614c2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225