Erythromycin Ethylsuccinate
- Product NDC
- 75834-294
- 11-digit product format
- 758340294
- Labeler code
- 75834
- Product ID
- 75834-294_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
- 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| Ingredient | Strength |
|---|
| ERYTHROMYCIN ETHYLSUCCINATE | 400 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1014KSJ86F |
| Rxcui | 686400, 686418 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-294-01 | Erythromycin Ethylsuccinate | 100 mL in 1 BOTTLE | SUSPENSION | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-294 | ERYTHROMYCIN ETHYLSUCCINATE SUSPENSION [NIVAGEN PHARMACEUTICALS, INC.] | 2 | Current NDC, 1 package rows | 20240117_46f74c4f-10fc-44cf-aec4-d113f49149bc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 75834-294-01 | 75834029401 | 100 mL in 1 BOTTLE (75834-294-01) | 100 ml | 2023-02-01 | No | No | Current |