Home NDC 24338-100 E.E.S
Product NDC 24338-100
11-digit product format 243380100
Labeler code 24338
Product ID 24338-100_0ca69356-c906-e9a9-e063-6394a90a9395
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Erythromycin Ethylsuccinate
Dosage form TABLET
Route ORAL
Labeler Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Application ANDA061905
Marketing category ANDA
Marketing start 2011-05-03
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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A061905-001 E.E.S. 400 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE TABLET / ORAL Approved before 1982 A061905-002 E.E.S. 400 ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A061905-002 BX
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A061905-001 E.E.S. 400 EQ 400MG BASE TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A061905-002 E.E.S. 400 EQ 400MG BASE TABLET / ORAL BX RS 1982-08-12 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base E.E.S
Brand name suffix 400
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014KSJ86F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 686400 Internal RxNorm lookup 686405 Internal RxNorm lookup 863603 Internal RxNorm lookup 863606 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 24338-100-03 E.E.S 400 30 in 1 BOTTLE TABLET 30 21 24338-100-13 E.E.S 400 100 in 1 BOTTLE TABLET 100 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Erythromycin Ethylsuccinate ACTIVE INGREDIENT 1014KSJ86F E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 Erythromycin ACTIVE MOIETY 63937KV33D E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 D&C Red No. 30 INACTIVE INGREDIENT 2S42T2808B E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 FD&C Red No. 3 INACTIVE INGREDIENT PN2ZH5LOQY E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 magnesium stearate INACTIVE INGREDIENT 70097M6I30 E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 polacrilin potassium INACTIVE INGREDIENT 0BZ5A00FQU E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 powdered cellulose INACTIVE INGREDIENT SMD1X3XO9M E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 sorbic acid INACTIVE INGREDIENT X045WJ989B E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 starch, corn INACTIVE INGREDIENT O8232NY3SJ E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 sucrose INACTIVE INGREDIENT C151H8M554 E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24338-100 E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)] 21 Current NDC, Legacy NDC, 2 package rows 20231217_b455bbdb-a3f1-470f-aa5f-ed83ac2e228d.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24338-100-03 24338010003 30 TABLET in 1 BOTTLE (24338-100-03) 30 tablet 2021-06-28 0000-00-00 No No Current 24338-100-13 24338010013 100 in 1 BOTTLE Historical