Azithromycin

Product NDC
35356-199
11-digit product format
353560199
Labeler code
35356
Product ID
35356-199_b1dd070c-6fe8-4230-960e-66a6ae1f840f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA065246
Marketing category
ANDA
Marketing start
2018-06-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35356-199DDiscontinued by firm2026-08-03
excluded packagepackage35356-19935356-199-15DDiscontinued by firm2026-08-03
excluded packagepackage35356-19935356-199-30DDiscontinued 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 · 36 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 packagepackage35356-199-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-199-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-199-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-199-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-199-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-199-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-199-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-199-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-199-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-199-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-199-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-199-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-199-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-199-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-199-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-199-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-199-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-199-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-199-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-199-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-199-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-199-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-199-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-199-15557ba5c1ecfa…9c80585c8c6e…

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
A065246-001AZITHROMYCINAZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05
A065246-002AZITHROMYCINAZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065246-001AB
A065246-002AB

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 UTC2026-02A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065246-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065246-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065246-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065246-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065246-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065246-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065246-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065246-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065246-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065246-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065246-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065246-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065246-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065246-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065246-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065246-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065246-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065246-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065246-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065246-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065246-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065246-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065246-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065246-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065246-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065246-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065246-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065246-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065246-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065246-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065246-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065246-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065246-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065246-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065246-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065246-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065246-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065246-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065246-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065246-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-199-15ML - Milliliter35356-1997ab0cbec-b8cb-4736-b5c6-f7f12bdd8dc912018-07-03
35356-199-30ML - Milliliter35356-199f51678f9-ceb7-4022-bf88-58f98429cb4e12018-12-13

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.ac327054-21ab-401c-a27a-48259db18f892026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246
AzithromycinAZITHROMYCINA-S Medication Solutionsf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b2024-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.549cdd0a-da79-23b8-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246
AzithromycinAZITHROMYCINProficient Rx LP44134421-cb0b-4e85-a3c8-d58bdb476fad2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246
AzithromycinAZITHROMYCINSTATE HEALTH SERVICES, TEXAS DEPARTMENT OF2b821631-0df2-0fb2-e054-00144ff8d46c2024-02-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246
AzithromycinAZITHROMYCINTeva Pharmaceuticals USA, Inc.3209b147-11ce-4eeb-8427-5f8e6fb2c83d2022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246