FDA.reportPublic FDA data

Erythromycin ethylsuccinate

Product NDC
71209-103
11-digit product format
712090103
Labeler code
71209
Product ID
71209-103_f9139eef-80df-428d-a326-a70cc827f9c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin ethylsuccinate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA216212
Marketing category
ANDA
Marketing start
2022-11-21
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
71209-103-21Erythromycin ethylsuccinate100 mL in 1 BOTTLEFOR SUSPENSION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-103ERYTHROMYCIN ETHYLSUCCINATE FOR SUSPENSION [CADILA PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 1 package rows20231119_db70798e-5e07-41d6-afe9-82c272bc5cc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686400erythromycin ethylsuccinate 200 MG in 5 mL Oral SuspensionPSNdb70798e-5e07-41d6-afe9-82c272bc5cc05
686418erythromycin ethylsuccinate 400 MG in 5 mL Oral SuspensionPSNdb70798e-5e07-41d6-afe9-82c272bc5cc05
686400erythromycin ethylsuccinate 40 MG/ML Oral SuspensionSCDdb70798e-5e07-41d6-afe9-82c272bc5cc05
686418erythromycin ethylsuccinate 80 MG/ML Oral SuspensionSCDdb70798e-5e07-41d6-afe9-82c272bc5cc05
686400EES 40 MG/ML Oral SuspensionSYdb70798e-5e07-41d6-afe9-82c272bc5cc05
686418EES 80 MG/ML Oral SuspensionSYdb70798e-5e07-41d6-afe9-82c272bc5cc05
686400erythromycin ethylsuccinate 200 MG per 5 ML Oral SuspensionSYdb70798e-5e07-41d6-afe9-82c272bc5cc05
686418erythromycin ethylsuccinate 400 MG per 5 ML Oral SuspensionSYdb70798e-5e07-41d6-afe9-82c272bc5cc05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-103-2171209010321100 mL in 1 BOTTLE (71209-103-21) 100 ml2022-11-210000-00-00NoNoCurrent