ERYTHROMYCIN ETHYLSUCCINATE

Product NDC
24338-110
Requested package NDC
24338-110-13
11-digit product format
243380110
Labeler code
24338
Product ID
24338-110_0ca6d238-d01f-04ea-e063-6394a90a7b84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Ethylsuccinate
Dosage form
TABLET
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Application
ANDA061904
Marketing category
ANDA
Marketing start
2011-10-03
Substance
ERYTHROMYCIN ETHYLSUCCINATE
Active strength
400 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage24338-11024338-110-13DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
A061904-001ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A061904-001BX

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 UTC2026-02A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061904-001ERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASETABLET / ORALBXRS, Approved before 1982cb3db0bc1861…

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 UTC2026-02A061904-001BX1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061904-001BX131067a03dcf5…
2025-08-23 18:47 UTC2025-08A061904-001BX16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061904-001BX1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061904-001BX1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061904-001BX103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061904-001BX12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061904-001BX15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061904-001BX1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061904-001BX1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061904-001BX179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061904-001BX1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061904-001BX11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061904-001BX18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061904-001BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061904-001BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061904-001BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061904-001BX174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061904-001BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A061904-001BX1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A061904-001BX187673890dc5c…
2021-03-12 10:30 UTC2021-03A061904-001BX15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A061904-001BX18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A061904-001BX1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A061904-001BX13f01610625f2…
2019-09-15 20:21 UTC2019-09A061904-001BX1b00525d2431f…
2019-07-19 19:46 UTC2019-07A061904-001BX1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A061904-001BX16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A061904-001BX11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A061904-001BX1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A061904-001BX1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A061904-001BX19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A061904-001BX1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A061904-001BX13f0d92c62455…
2023-05-13 08:27 UTC2023-05A061904-001BX1053a50430f4f…
2023-01-26 05:58 UTC2023-01A061904-001BX13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A061904-001BX13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A061904-001BX1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A061904-001BX1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061904-001BX1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
ERYTHROMYCIN ETHYLSUCCINATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN ETHYLSUCCINATE400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014KSJ86FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
686405Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
23a0564e-dca9-41bc-b2c7-0461169f65f9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24338-110-03ERYTHROMYCIN ETHYLSUCCINATE30 in 1 BOTTLETABLET3015
24338-110-13ERYTHROMYCIN ETHYLSUCCINATE100 in 1 BOTTLETABLET10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-110-03EA - Each24338-110a29b7cfd-e1f7-44c8-89b1-73c84f811d6012021-02-05
24338-110-13EA - Each24338-1101a5de365-ee0f-4ed9-8c21-c4ebde8ee45512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-110ERYTHROMYCIN ETHYLSUCCINATE TABLET [AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)]15Current NDC, Legacy NDC, 2 package rows20231217_23a0564e-dca9-41bc-b2c7-0461169f65f9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATEAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)23a0564e-dca9-41bc-b2c7-0461169f65f92023-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061904
application number: ANDA061904
ndc (package): 24338-110-13
ndc (product): 24338-110
ndc11 (package): 24338011013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686405erythromycin ethylsuccinate 400 MG Oral TabletPSN23a0564e-dca9-41bc-b2c7-0461169f65f915
686405erythromycin ethylsuccinate 400 MG Oral TabletSCD23a0564e-dca9-41bc-b2c7-0461169f65f915
686405EES 400 MG Oral TabletSY23a0564e-dca9-41bc-b2c7-0461169f65f915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-110-1324338011013100 TABLET in 1 BOTTLE (24338-110-13) 100 tablet2011-10-030000-00-00NoNoCurrent