FDA.reportPublic FDA data

Erythromycin Ethylsuccinate

Product NDC
75834-295
11-digit product format
758340295
Labeler code
75834
Product ID
75834-295_7f06e8f4-15fb-4e18-b57e-457e7e20d331
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Ethylsuccinate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA216212
Marketing category
ANDA
Marketing start
2023-02-01
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, 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
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
75834-295-01Erythromycin Ethylsuccinate100 mL in 1 BOTTLESUSPENSION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-295-01ML - Milliliter75834-295e993f7f6-1cc2-48c5-8f1d-49c12475441f12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-295ERYTHROMYCIN ETHYLSUCCINATE SUSPENSION [NIVAGEN PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20240117_46f74c4f-10fc-44cf-aec4-d113f49149bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686400erythromycin ethylsuccinate 200 MG in 5 mL Oral SuspensionPSN46f74c4f-10fc-44cf-aec4-d113f49149bc2
686418erythromycin ethylsuccinate 400 MG in 5 mL Oral SuspensionPSN46f74c4f-10fc-44cf-aec4-d113f49149bc2
686400erythromycin ethylsuccinate 40 MG/ML Oral SuspensionSCD46f74c4f-10fc-44cf-aec4-d113f49149bc2
686418erythromycin ethylsuccinate 80 MG/ML Oral SuspensionSCD46f74c4f-10fc-44cf-aec4-d113f49149bc2
686400EES 40 MG/ML Oral SuspensionSY46f74c4f-10fc-44cf-aec4-d113f49149bc2
686418EES 80 MG/ML Oral SuspensionSY46f74c4f-10fc-44cf-aec4-d113f49149bc2
686400erythromycin ethylsuccinate 200 MG per 5 ML Oral SuspensionSY46f74c4f-10fc-44cf-aec4-d113f49149bc2
686418erythromycin ethylsuccinate 400 MG per 5 ML Oral SuspensionSY46f74c4f-10fc-44cf-aec4-d113f49149bc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75834-295-0175834029501100 mL in 1 BOTTLE (75834-295-01) 100 ml2023-02-01NoNoCurrent