erythromycin lactobionate
- Product NDC
- 68083-513
- 11-digit product format
- 680830513
- Labeler code
- 68083
- Product ID
- 68083-513_62d03a60-5432-4fa9-a4bb-e14276b78b47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- erythromycin lactobionate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA216761
- Marketing category
- ANDA
- Marketing start
- 2024-11-19
- Substance
- ERYTHROMYCIN LACTOBIONATE
- Active strength
- 500 mg/10mL
- 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 lactobionate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ERYTHROMYCIN LACTOBIONATE | 500 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33H58I7GLQ |
| Rxcui | 1668264 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-513-01 | erythromycin lactobionate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 4 |
| 68083-513-10 | erythromycin lactobionate | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-513 | ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 4 | Current NDC, 2 package rows | 20241123_c6f9565b-6d9d-40e3-87f8-9f38ede9173a.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 |
|---|
| 68083-513-01 | 68083051301 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |
| 68083-513-10 | 68083051310 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01) | | 2024-11-19 | No | No | Current |