Azithromycin

Product NDC
0781-1496
11-digit product format
007811496
Labeler code
0781
Product ID
0781-1496_fe925fb2-7067-4951-a3b3-93296689e550
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065211
Marketing category
ANDA
Marketing start
2005-11-14
Marketing end
2020-09-30
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-1496DDiscontinued by firm2026-08-03
excluded packagepackage0781-14960781-1496-01DDiscontinued by firm2026-08-03
excluded packagepackage0781-14960781-1496-31DDiscontinued by firm2026-08-03
excluded packagepackage0781-14960781-1496-68DDiscontinued by firm2026-08-03
excluded packagepackage0781-14960781-1496-69DDiscontinued 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 · 60 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 packagepackage0781-1496-68d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-1496-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-1496-69d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-1496-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-1496-68f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-1496-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-1496-69f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-1496-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-1496-682ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-1496-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-1496-692ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-1496-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-1496-68a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-1496-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-1496-69a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-1496-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-1496-68cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-1496-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-1496-69cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-1496-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-1496-68cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-1496-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-1496-69cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-1496-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-1496-68302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-1496-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-1496-69302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-1496-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-1496-68ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-1496-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-1496-69ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-1496-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-1496-680efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-1496-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-1496-690efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-1496-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-1496-68ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-1496-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-1496-69ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-1496-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-1496-68367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-1496-31367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-1496-69367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-1496-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-1496-68557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-1496-31557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-1496-69557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-1496-01557ba5c1ecfa…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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1496-31EA - Each0781-1496bf8085d1-664a-4424-ba26-e01b047a55f312012-07-24
0781-1496-68EA - Each0781-14966f567724-62f7-4af3-9efb-aa149bad2e7712012-07-24
0781-1496-69EA - Each0781-1496fd91bfa6-30db-4afd-94c2-c52c214ad08f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
AZITHROMYCINACTIVE INGREDIENTF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1

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
308460azithromycin 250 MG Oral TabletPSN7f6c0f30-2f11-4d08-b478-3ff5e170511910
308460azithromycin 250 MG Oral TabletSCD7f6c0f30-2f11-4d08-b478-3ff5e170511910
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK4a13b574-ff5e-417e-bef4-279fcc3d52803
308460azithromycin 250 MG Oral TabletPSN00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
308460azithromycin 250 MG Oral TabletPSN4a13b574-ff5e-417e-bef4-279fcc3d52803
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN4a13b574-ff5e-417e-bef4-279fcc3d52803
248656azithromycin 500 MG Oral TabletPSN4a13b574-ff5e-417e-bef4-279fcc3d52803
308460azithromycin 250 MG Oral TabletSCD00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
308460azithromycin 250 MG Oral TabletSCD4a13b574-ff5e-417e-bef4-279fcc3d52803
248656azithromycin 500 MG Oral TabletSCD4a13b574-ff5e-417e-bef4-279fcc3d52803
749783azithromycin 250 MG Oral Tablet 6 Count PackSY00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
749783azithromycin 250 MG Oral Tablet 6 Count PackSY4a13b574-ff5e-417e-bef4-279fcc3d52803
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY4a13b574-ff5e-417e-bef4-279fcc3d52803
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK4ece67c7-b351-48bf-8488-8238279522721
308460azithromycin 250 MG Oral TabletPSN4ece67c7-b351-48bf-8488-8238279522721
308460azithromycin 250 MG Oral TabletPSN10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN4ece67c7-b351-48bf-8488-8238279522721
308460azithromycin 250 MG Oral TabletSCD10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
308460azithromycin 250 MG Oral TabletSCD4ece67c7-b351-48bf-8488-8238279522721
749783azithromycin 250 MG Oral Tablet 6 Count PackSY4ece67c7-b351-48bf-8488-8238279522721
749783azithromycin 250 MG Oral Tablet 6 Count PackSY10aebebe-98b3-4f35-b9cb-dba5e3505f1e1