FDA.reportPublic FDA data

Erythromycin Ethylsuccinate

Product NDC
52536-136
11-digit product format
525360136
Labeler code
52536
Product ID
52536-136_98a85646-cc9b-429f-9b46-4a3ce1b5c129
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Ethylsuccinate
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Wilshire Pharmaceuticals Inc.
Application
NDA050207
Marketing category
NDA
Marketing start
2016-09-28
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
52536-136-13Erythromycin Ethylsuccinate200 mL in 1 BOTTLEGRANULE, FOR SUSPENSION2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52536-136-13ML - Milliliter52536-1369b8b94f8-1f09-4461-8f8b-759b616f5e4012016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52536-136ERYTHROMYCIN ETHYLSUCCINATE GRANULE, FOR SUSPENSION [WILSHIRE PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20190131_f4a3fffd-ce02-450f-bbcc-d425374e3e32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686400erythromycin ethylsuccinate 200 MG in 5 mL Oral SuspensionPSNf4a3fffd-ce02-450f-bbcc-d425374e3e323
686400erythromycin ethylsuccinate 40 MG/ML Oral SuspensionSCDf4a3fffd-ce02-450f-bbcc-d425374e3e323
686400EES 40 MG/ML Oral SuspensionSYf4a3fffd-ce02-450f-bbcc-d425374e3e323
686400erythromycin ethylsuccinate 200 MG per 5 ML Oral SuspensionSYf4a3fffd-ce02-450f-bbcc-d425374e3e323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52536-136-1352536013613200 mL in 1 BOTTLE (52536-136-13) 200 ml2016-09-280000-00-00NoNoCurrent