FDA.reportPublic FDA data

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

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
IngredientStrength
ERYTHROMYCIN ETHYLSUCCINATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1014KSJ86F
Rxcui686400, 686405, 863603, 863606

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
24338-100-03E.E.S 40030 in 1 BOTTLETABLET3021
24338-100-13E.E.S 400100 in 1 BOTTLETABLET10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-100-03EA - Each24338-100ca5a8285-de04-43bf-9c4e-e3ddc0a69cde12021-08-05
24338-100-13EA - Each24338-100a146b95d-9b8e-4334-b4b1-987742296ff312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Erythromycin EthylsuccinateACTIVE INGREDIENT1014KSJ86FE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
ErythromycinACTIVE MOIETY63937KV33DE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
D&C Red No. 30INACTIVE INGREDIENT2S42T2808BE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
magnesium stearateINACTIVE INGREDIENT70097M6I30E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
polacrilin potassiumINACTIVE INGREDIENT0BZ5A00FQUE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9ME.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
propylene glycolINACTIVE INGREDIENT6DC9Q167V3E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
sorbic acidINACTIVE INGREDIENTX045WJ989BE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
starch, cornINACTIVE INGREDIENTO8232NY3SJE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
sucroseINACTIVE INGREDIENTC151H8M554E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPE.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
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-100E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)]21Current NDC, Legacy NDC, 2 package rows20231217_b455bbdb-a3f1-470f-aa5f-ed83ac2e228d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863603E.E.S. 200 MG in 5 mL Oral SuspensionPSNb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863606E.E.S. 400 MG Oral TabletPSNb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686400erythromycin ethylsuccinate 200 MG in 5 mL Oral SuspensionPSNb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686405erythromycin ethylsuccinate 400 MG Oral TabletPSNb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863603erythromycin ethylsuccinate 40 MG/ML Oral Suspension [E.E.S.]SBDb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863606erythromycin ethylsuccinate 400 MG Oral Tablet [E.E.S.]SBDb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686400erythromycin ethylsuccinate 40 MG/ML Oral SuspensionSCDb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686405erythromycin ethylsuccinate 400 MG Oral TabletSCDb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863603E.E.S. 200 MG per 5 ML Oral SuspensionSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863603E.E.S. 200 Oral SuspensionSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863603E.E.S. 40 MG/ML Oral SuspensionSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863606E.E.S. 400 MG Oral TabletSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686400EES 40 MG/ML Oral SuspensionSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863603EES 40 MG/ML Oral Suspension [E.E.S.]SYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686405EES 400 MG Oral TabletSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863606EES 400 MG Oral Tablet [E.E.S.]SYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686400erythromycin ethylsuccinate 200 MG per 5 ML Oral SuspensionSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-100-032433801000330 TABLET in 1 BOTTLE (24338-100-03) 30 tablet2021-06-280000-00-00NoNoCurrent
24338-100-1324338010013100 in 1 BOTTLEHistorical