Azithromycin

Product NDC
0093-7169
11-digit product format
000937169
Labeler code
0093
Product ID
0093-7169_663c9c2a-f6ce-43e4-b229-1f3328dd24a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA,
Application
ANDA065193
Marketing category
ANDA
Marketing start
2005-11-16
Marketing end
2020-01-31
Substance
AZITHROMYCIN MO
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antim
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-7169DDiscontinued by firm2026-10-05
excluded packagepackage0093-71690093-7169-56DDiscontinued by firm2026-10-05
excluded packagepackage0093-71690093-7169-90DDiscontinued by firm2026-10-05
excluded packagepackage0093-71690093-7169-93DDiscontinued by firm2026-10-05

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 · 48 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 packagepackage0093-7169-56d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-7169-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-7169-93d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7169-56f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7169-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7169-93f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7169-562ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7169-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7169-932ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7169-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7169-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7169-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7169-56cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7169-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7169-93cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7169-56cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7169-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7169-93cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7169-56302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7169-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7169-93302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7169-56ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7169-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7169-93ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7169-560efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7169-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7169-930efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7169-56ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7169-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7169-93ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7169-56367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7169-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7169-93367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7169-56557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7169-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7169-93557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065193-001AZITHROMYCINAZITHROMYCINEQ 500MG 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
A065193-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1484e616aacf4f…
2026-08-18 06:07:402026-07A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065193-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065193-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A065193-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065193-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065193-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065193-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065193-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065193-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065193-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065193-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065193-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065193-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065193-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065193-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065193-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065193-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065193-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065193-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065193-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065193-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065193-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065193-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065193-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065193-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065193-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065193-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065193-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065193-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065193-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065193-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065193-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065193-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065193-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065193-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065193-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065193-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065193-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065193-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065193-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065193-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065193-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0093-7169-33EA - Each0093-7169b58c867a-8de5-478f-9a9d-e6d6694c198512012-07-24
0093-7169-56EA - Each0093-716982f4d6de-1474-417e-9b78-acf77579c8c412012-07-24
0093-7169-90EA - Each0093-7169181d44ee-3b87-4818-a829-8da19df081bd12012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNf5e6086e-6a9e-4126-8f5c-848862c521e63
248656azithromycin 500 MG Oral TabletSCDf5e6086e-6a9e-4126-8f5c-848862c521e63
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYf5e6086e-6a9e-4126-8f5c-848862c521e63