Azithromycin

Product NDC
50436-1496
11-digit product format
504361496
Labeler code
50436
Product ID
50436-1496_c9c07e01-3d5c-4535-8b04-f386b8ca65a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA065211
Marketing category
ANDA
Marketing start
2005-11-14
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 productproduct50436-1496IInactivated by FDA2026-08-03
excluded packagepackage50436-149650436-1496-1IInactivated by FDA2026-08-03

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 · 38 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 packagepackage50436-1496-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-1496-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-1496-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-1496-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-1496-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-1496-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-1496-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-1496-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-1496-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-1496-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-1496-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-1496-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-1496-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-1496-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-1496-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-1496-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-1496-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-1496-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-1496-18dfbde2a14a4…c9ff85d89658…

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
A065211-001AZITHROMYCINAZITHROMYCINEQ 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
A065211-001AB

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 UTC2026-02A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065211-001AZITHROMYCINEQ 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 UTC2026-02A065211-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065211-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065211-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065211-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065211-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065211-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065211-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065211-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065211-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065211-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065211-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065211-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065211-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065211-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065211-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065211-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065211-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065211-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065211-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065211-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065211-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065211-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065211-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065211-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065211-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065211-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065211-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065211-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065211-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065211-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065211-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065211-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065211-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065211-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065211-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065211-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065211-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065211-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065211-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065211-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-1496-1Azithromycin3 in 1 CARTONTABLET, FILM COATED33
50436-1496-1Azithromycin6 in 1 DOSE PACKTABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1496AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]3Legacy NDC, 2 package rows20170228_00a7dad6-0bfc-4ccc-b261-3e0004b4c659.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.661ff7a6-6394-493d-a307-a1f607e5d1172026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065211
application number: ANDA065211
AzithromycinAZITHROMYCINSportpharm LLC60ec2020-148b-4a2a-96f2-dd09c590ecbb2026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065211
application number: ANDA065211
AzithromycinAZITHROMYCINAsclemed USA, Inc.22a4d2b3-daea-4d96-891f-4b98236294562024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065211
application number: ANDA065211
AzithromycinAZITHROMYCINProficient Rx LP38942011-f86b-4e42-a4ca-05a70d9dd3d92024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065211
application number: ANDA065211
AzithromycinAZITHROMYCINSandoz Incec619299-e0ef-44dd-acdb-8c53bbfc5b8a2022-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065211
application number: ANDA065211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
308460azithromycin 250 MG Oral TabletPSN00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
308460azithromycin 250 MG Oral TabletSCD00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
749783azithromycin 250 MG Oral Tablet 6 Count PackSY00a7dad6-0bfc-4ccc-b261-3e0004b4c6593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-1496-1504361496013 in 1 CARTONHistorical