FDA.reportPublic FDA data

E.E.S

Product NDC
80005-161
11-digit product format
800050161
Labeler code
80005
Product ID
80005-161_ad0b7a24-6fae-4dfd-a308-4fd9c543d7e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Ethylsuccinate
Dosage form
TABLET
Route
ORAL
Labeler
Carnegie Pharmaceuticals LLC
Application
ANDA061905
Marketing category
ANDA
Marketing start
2025-01-15
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
80005-161-08E.E.S 40030 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80005-161-08EA - Each80005-161fbff54ca-7ad0-453d-905b-973049c7cbc812025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80005-161E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [CARNEGIE PHARMACEUTICALS LLC]2Current NDC, 1 package rows20250226_91479d92-3bf3-4eb3-81bd-8ce4956d4347.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863603E.E.S. 200 MG in 5 mL Oral SuspensionPSN91479d92-3bf3-4eb3-81bd-8ce4956d43472
863606E.E.S. 400 MG Oral TabletPSN91479d92-3bf3-4eb3-81bd-8ce4956d43472
686400erythromycin ethylsuccinate 200 MG in 5 mL Oral SuspensionPSN91479d92-3bf3-4eb3-81bd-8ce4956d43472
686405erythromycin ethylsuccinate 400 MG Oral TabletPSN91479d92-3bf3-4eb3-81bd-8ce4956d43472
863603erythromycin ethylsuccinate 40 MG/ML Oral Suspension [E.E.S.]SBD91479d92-3bf3-4eb3-81bd-8ce4956d43472
863606erythromycin ethylsuccinate 400 MG Oral Tablet [E.E.S.]SBD91479d92-3bf3-4eb3-81bd-8ce4956d43472
686400erythromycin ethylsuccinate 40 MG/ML Oral SuspensionSCD91479d92-3bf3-4eb3-81bd-8ce4956d43472
686405erythromycin ethylsuccinate 400 MG Oral TabletSCD91479d92-3bf3-4eb3-81bd-8ce4956d43472
863603E.E.S. 200 MG per 5 ML Oral SuspensionSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
863603E.E.S. 200 Oral SuspensionSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
863603E.E.S. 40 MG/ML Oral SuspensionSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
863606E.E.S. 400 MG Oral TabletSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
686400EES 40 MG/ML Oral SuspensionSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
863603EES 40 MG/ML Oral Suspension [E.E.S.]SY91479d92-3bf3-4eb3-81bd-8ce4956d43472
686405EES 400 MG Oral TabletSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
863606EES 400 MG Oral Tablet [E.E.S.]SY91479d92-3bf3-4eb3-81bd-8ce4956d43472
686400erythromycin ethylsuccinate 200 MG per 5 ML Oral SuspensionSY91479d92-3bf3-4eb3-81bd-8ce4956d43472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80005-161-088000501610830 TABLET in 1 BOTTLE (80005-161-08) 30 tablet2025-01-15NoNoCurrent