Prescription drug · ANDA
Erythromycin ethylsuccinate NDC 85742-029
Erythromycin ethylsuccinate 200 mg/5mL · For suspension · Oral · Kanchan Healthcare Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85742-029-28 | 85742002928 | 100 mL in 1 BOTTLE (85742-029-28)Marketed from Nov 21, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Erythromycin ethylsuccinate
- Generic name (nonproprietary)
- erythromycin ethylsuccinate
- Active ingredients
- Erythromycin ethylsuccinate — 200 mg/5mL
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- Kanchan Healthcare Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216212
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 85742-029_56b7e7ad-dd16-44aa-8b65-0fb27e5f49b4SPL ID 56b7e7ad-dd16-44aa-8b65-0fb27e5f49b4SPL set ID a7f7faaf-dc05-4d51-86c6-bf5d61562e48RxCUI 686400, 686418UNII 1014KSJ86FUPC 0385742030288, 0385742029282
- Pharmacologic class
- Macrolide Antimicrobial; Macrolide
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485742002928followed by a unit qualifier and the quantityPackage 85742-0029-28. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate for oral suspension is indicated in the treatme…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216212
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Erythromycin Ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | SuspensionOral | Nivagen Pharmaceuticals, Inc. | 75834-295 |
| Erythromycin Ethylsuccinate | Erythromycin ethylsuccinate 400 mg/5mL | SuspensionOral | Nivagen Pharmaceuticals, Inc. | 75834-294 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 72162-2657 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 400 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 72162-2658 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | For suspensionOral | Cadila Pharmaceuticals Limited | 71209-102 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 400 mg/5mL | For suspensionOral | Cadila Pharmaceuticals Limited | 71209-103 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 400 mg/5mL | For suspensionOral | Kanchan Healthcare Inc | 85742-030 |