FDA.reportPublic FDA data

Erythromycin Ethylsuccinate

Product NDC
62559-631
11-digit product format
625590631
Labeler code
62559
Product ID
62559-631_9bae85e8-ec96-4424-a640-27860f8f319e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Ethylsuccinate
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA062055
Marketing category
ANDA
Marketing start
2019-03-25
Substance
ERYTHROMYCIN ETHYLSUCCINATE
Active strength
400 mg/5mL
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
Erythromycin Ethylsuccinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN ETHYLSUCCINATE400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1014KSJ86F
Rxcui686400, 686418

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
62559-631-01Erythromycin Ethylsuccinate100 mL in 1 BOTTLEGRANULE, FOR SUSPENSION1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-631-01ML - Milliliter62559-63134eaa970-e0d6-44f5-8b0f-911f2c8d76c212019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-631ERYTHROMYCIN ETHYLSUCCINATE GRANULE, FOR SUSPENSION [ANI PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20190325_3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686400erythromycin ethylsuccinate 200 MG in 5 mL Oral SuspensionPSN3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f3
686418erythromycin ethylsuccinate 400 MG in 5 mL Oral SuspensionPSN3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f3
686400erythromycin ethylsuccinate 40 MG/ML Oral SuspensionSCD3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f3
686418erythromycin ethylsuccinate 80 MG/ML Oral SuspensionSCD3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f3
686400EES 40 MG/ML Oral SuspensionSY3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f3
686418EES 80 MG/ML Oral SuspensionSY3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f3
686400erythromycin ethylsuccinate 200 MG per 5 ML Oral SuspensionSY3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f3
686418erythromycin ethylsuccinate 400 MG per 5 ML Oral SuspensionSY3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-631-0162559063101100 mL in 1 BOTTLE (62559-631-01) 100 ml2019-03-250000-00-00NoNoCurrent