Azithromycin

Product NDC
70518-0599
11-digit product format
705180599
Labeler code
70518
Product ID
70518-0599_47fa21e2-07c3-16d5-e063-6394a90abf0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065223
Marketing category
ANDA
Marketing start
2017-06-28
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage70518-059970518-0599-1DDiscontinued by firm2026-08-03
excluded packagepackage70518-059970518-0599-2DDiscontinued by firm2026-08-03
excluded packagepackage70518-059970518-0599-4DDiscontinued by firm2026-08-03
excluded packagepackage70518-059970518-0599-5DDiscontinued 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 · 56 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-0599-4DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-0599-5DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-0599-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-0599-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-0599-4DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-0599-5DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-0599-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-0599-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-0599-5DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-0599-4DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-0599-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-0599-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-0599-5DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-0599-4DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-0599-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-0599-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-0599-5DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-0599-4DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-0599-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-0599-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-0599-5DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-0599-4DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-0599-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-0599-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-0599-5DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-0599-4DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-0599-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-0599-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-0599-5DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-0599-4DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-0599-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-0599-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-0599-4DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-0599-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-0599-5DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-0599-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-0599-4DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-0599-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-0599-5DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-0599-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-0599-4DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-0599-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-0599-5DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-0599-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-0599-4DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-0599-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-0599-5DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-0599-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70518-0599-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70518-0599-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70518-0599-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70518-0599-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70518-0599-0IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70518-0599-2IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A065223-001AZITHROMYCINAZITHROMYCINEQ 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
A065223-001AB

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 UTC2026-02A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065223-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2005-11-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065223-001AZITHROMYCINEQ 500MG 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 UTC2026-02A065223-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065223-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065223-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065223-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065223-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065223-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065223-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065223-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065223-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065223-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065223-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065223-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065223-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065223-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065223-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065223-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065223-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065223-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065223-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065223-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065223-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065223-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065223-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065223-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065223-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065223-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065223-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065223-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065223-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065223-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065223-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065223-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065223-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065223-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065223-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065223-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065223-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065223-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065223-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065223-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN MONOHYDRATE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JTE4MNN1MDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248656Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
943b9246-7733-44b1-875c-91d2ade78ac4Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70518-0599-02021-04-05These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-02021-04-05These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-02021-04-05These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-12021-04-05These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-12021-04-05These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-12021-04-05These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-22021-04-05These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-22021-04-05These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-22021-04-05These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-02020-01-31These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-02020-01-31These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-02020-01-31These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-12020-01-31These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-12020-01-31These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-12020-01-31These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-22020-01-31These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-22020-01-31These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-0599-22020-01-31These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0599-0Azithromycin2 in 1 BOXTABLET, FILM COATED217
70518-0599-1Azithromycin30 in 1 BLISTER PACKTABLET, FILM COATED3017
70518-0599-2Azithromycin3 in 1 BOTTLE, PLASTICTABLET, FILM COATED317
70518-0599-3Azithromycin2 in 1 BOTTLE, PLASTICTABLET, FILM COATED217
70518-0599-4Azithromycin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2017
70518-0599-5Azithromycin2 in 1 BOTTLE, PLASTICTABLET, FILM COATED217
70518-0599-6Azithromycin1 in 1 POUCHTABLET, FILM COATED117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0599-0EA - Each70518-05993961efc5-a6ea-4aa3-a357-d347890a018912026-01-08
70518-0599-3EA - Each70518-0599bdc608e8-c4d3-4711-aa90-9796c683af5612026-01-08
70518-0599-6EA - Each70518-0599fefaa58b-ae47-4163-b5f6-d7908f41ef1812026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0599AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 7 package rows20250429_943b9246-7733-44b1-875c-91d2ade78ac4.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
AzithromycinAZITHROMYCINREMEDYREPACK INC.943b9246-7733-44b1-875c-91d2ade78ac42026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065223
application number: ANDA065223
ndc (product): 70518-0599
AzithromycinAZITHROMYCINSportpharm LLC397471e5-76e2-462c-af30-bcc54fe002662026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065223
application number: ANDA065223
AzithromycinAZITHROMYCINAsclemed USA, Inc.9c44af6d-8a9a-cb4c-e053-2a95a90afdac2023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065223
application number: ANDA065223
AzithromycinAZITHROMYCINTeva Pharmaceuticals USA, Inc.f6a52c0b-45db-422e-8c22-e867a11b44392023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065223
application number: ANDA065223
AzithromycinAZITHROMYCINProficient Rx LP7e7c2f49-449c-4ba2-98ae-0ff0c040614c2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065223
application number: ANDA065223

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN943b9246-7733-44b1-875c-91d2ade78ac417
248656azithromycin 500 MG Oral TabletSCD943b9246-7733-44b1-875c-91d2ade78ac417
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY943b9246-7733-44b1-875c-91d2ade78ac417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0599-0705180599002 POUCH in 1 BOX (70518-0599-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-0599-6) 2 pouch2017-06-280000-00-00NoNoCurrent
70518-0599-17051805990130 TABLET, FILM COATED in 1 BLISTER PACK (70518-0599-1) 2017-11-150000-00-00NoNoCurrent
70518-0599-2705180599023 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-2) 2018-05-140000-00-00NoNoCurrent
70518-0599-3705180599032 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-3) 2020-04-230000-00-00NoNoCurrent
70518-0599-47051805990420 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-4) 2021-01-210000-00-00NoNoCurrent
70518-0599-5705180599052 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-5) 2021-05-030000-00-00NoNoCurrent
70518-0599-6705180599061 in 1 POUCHHistorical