FDA.reportPublic FDA data

Erythromycin Ethylsuccinate

Product NDC
62559-440
11-digit product format
625590440
Labeler code
62559
Product ID
62559-440_f11e2e76-7778-4d82-961d-a16dd2bc84ae
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
2016-09-27
Substance
ERYTHROMYCIN ETHYLSUCCINATE
Active strength
200 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 ETHYLSUCCINATE200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1014KSJ86F
Rxcui686400

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
62559-440-01Erythromycin Ethylsuccinate100 mL in 1 BOTTLEGRANULE, FOR SUSPENSION10010
62559-440-02Erythromycin Ethylsuccinate200 mL in 1 BOTTLEGRANULE, FOR SUSPENSION20010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-440-01ML - Milliliter62559-44087623d77-27d2-4be3-a995-0233e16c999512016-10-06
62559-440-02ML - Milliliter62559-44062dde642-c570-4390-b1eb-7aed71b697f812016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-440ERYTHROMYCIN ETHYLSUCCINATE GRANULE, FOR SUSPENSION [ANI PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20231220_3de1e0b9-473b-44c0-a644-5fa14ad69a83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686400erythromycin ethylsuccinate 200 MG in 5 mL Oral SuspensionPSN3de1e0b9-473b-44c0-a644-5fa14ad69a8310
686400erythromycin ethylsuccinate 40 MG/ML Oral SuspensionSCD3de1e0b9-473b-44c0-a644-5fa14ad69a8310
686400EES 40 MG/ML Oral SuspensionSY3de1e0b9-473b-44c0-a644-5fa14ad69a8310
686400erythromycin ethylsuccinate 200 MG per 5 ML Oral SuspensionSY3de1e0b9-473b-44c0-a644-5fa14ad69a8310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-440-0162559044001100 mL in 1 BOTTLE (62559-440-01) 100 ml2016-09-270000-00-00NoNoCurrent
62559-440-0262559044002200 mL in 1 BOTTLE (62559-440-02) 200 ml2016-09-270000-00-00NoNoCurrent