AZITHROMYCIN MONOHYDRATE

Product NDC
61919-096
11-digit product format
619190096
Labeler code
61919
Product ID
61919-096_9c5970fb-9ba5-6e87-e053-2a95a90a6889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN MONOHYDRATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA065399
Marketing category
ANDA
Marketing start
2017-03-08
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct61919-096IInactivated by FDA2026-08-07
excluded packagepackage61919-09661919-096-03IInactivated by FDA2026-08-07

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 · 32 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-096-03IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-096-03IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-096-03IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-096-03IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-096-03IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-096-03IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-096-03IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-096-03IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-096-03IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-096-03IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-096-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-096-03IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-096-03IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-096-03IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-096-03IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-096-03EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A065399-001AZITHROMYCINAZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065399-001AB

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 UTC2026-02A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15cb3db0bc1861…

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 UTC2026-02A065399-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065399-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065399-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065399-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065399-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065399-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065399-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065399-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065399-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065399-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065399-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065399-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065399-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065399-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065399-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065399-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065399-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065399-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065399-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065399-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065399-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065399-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065399-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065399-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065399-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065399-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065399-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065399-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065399-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065399-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065399-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065399-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065399-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065399-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065399-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065399-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065399-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065399-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065399-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065399-001AB1cb3db0bc1861…

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-096-032023-01-30C16284748780-1f386c649-f491-0266-e053-dadaa90a7c1aAZITHROMYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-096-03AZITHROMYCIN MONOHYDRATE3 in 1 BLISTER PACKTABLET32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-096AZITHROMYCIN MONOHYDRATE TABLET [DIRECT RX]2Legacy NDC, 1 package rows20200128_4a3a000d-baee-74a3-e054-00144ff88e88.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
azithromycinAZITHROMYCINLupin Pharmaceuticals, Inc.01649d79-4677-4577-a3e4-e054f3f9fc3b2025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065399
application number: ANDA065399
azithromycinAZITHROMYCINREMEDYREPACK INC.bf061799-cdef-40f8-b1ce-bc5eb609f8c32025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065399
application number: ANDA065399
azithromycinAZITHROMYCINMajor Pharmaceuticals814abe38-da4a-48af-bf4b-2ce04a5aabd12025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065399
application number: ANDA065399
AzithromycinAZITHROMYCINAmerican Health Packaging6169e56c-10fb-448d-ab0f-14e54fcf28172025-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065399
application number: ANDA065399
azithromycin dihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLC1cec44fa-9597-3e58-e063-6394a90ae3262024-07-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065399
application number: ANDA065399

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN4a3a000d-baee-74a3-e054-00144ff88e882
248656azithromycin 500 MG Oral TabletSCD4a3a000d-baee-74a3-e054-00144ff88e882
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY4a3a000d-baee-74a3-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-096-03619190096033 TABLET in 1 BLISTER PACK (61919-096-03) 3 tablet2017-03-080000-00-00NoNoCurrent