Azithromycin

Product NDC
66116-524
11-digit product format
661160524
Labeler code
66116
Product ID
66116-524_4e9ac94f-4d85-4731-8b7f-6188209b4a9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Monohydrate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA065419
Marketing category
ANDA
Marketing start
2008-09-22
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct66116-524IInactivated by FDA2026-08-03
excluded packagepackage66116-52466116-524-30IInactivated 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 · 44 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 packagepackage66116-524-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66116-524-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66116-524-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66116-524-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66116-524-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66116-524-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66116-524-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66116-524-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66116-524-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66116-524-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66116-524-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66116-524-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66116-524-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66116-524-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66116-524-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66116-524-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66116-524-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66116-524-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66116-524-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66116-524-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66116-524-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66116-524-30110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065419-001AZITHROMYCINAZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24
A065419-002AZITHROMYCINAZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2008-06-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2008-06-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065419-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A065419-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORAL2008-06-24782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A065419-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065419-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A065419-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A065419-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065419-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065419-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065419-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065419-002AB1ea99ee380514…

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
66116-524-302019-11-27C16284748780-19855e2a2-377d-60a7-e053-dbdaa90a05bdAzithromycin for Oral Suspension USP 7148 7149 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-524-30Azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-524AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1Legacy NDC, 1 package rows20140328_4e9ac94f-4d85-4731-8b7f-6188209b4a9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN4e9ac94f-4d85-4731-8b7f-6188209b4a9c1
141963azithromycin 40 MG/ML Oral SuspensionSCD4e9ac94f-4d85-4731-8b7f-6188209b4a9c1
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY4e9ac94f-4d85-4731-8b7f-6188209b4a9c1
141963azithromycin 200 MG per 5 ML Oral SuspensionSY4e9ac94f-4d85-4731-8b7f-6188209b4a9c1
141963azithromycin 600 MG per 15 ML Oral SuspensionSY4e9ac94f-4d85-4731-8b7f-6188209b4a9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66116-524-306611605243030 mL in 1 BOTTLE30 mlHistorical