Prescription drug · ANDA
Erythromycin NDC 52536-183
Erythromycin 333 mg/1 · Tablet, Delayed release · Oral · Wilshire Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-183-03 | 52536018303 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (52536-183-03)Marketed from Jul 22, 2019 | |
| 52536-183-10 | 52536018310 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (52536-183-10)Marketed from Jul 22, 2019 |
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
- Generic name (nonproprietary)
- erythromycin
- Active ingredients
- Erythromycin — 333 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Wilshire Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062298
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 52536-183_292b4c82-0b72-5283-e063-6394a90ad2acSPL ID 292b4c82-0b72-5283-e063-6394a90ad2acSPL set ID e9b5abbb-2952-44ce-8cbb-415d9be23df4RxCUI 310155, 310157, 315090UNII 63937KV33D
- 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
N452536018303followed by a unit qualifier and the quantityPackage 52536-0183-03. 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 Delayed-Release Tablets and other antibacterial drugs, Erythromycin Delayed-Release Tablets 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 Delayed-Release Tablets are indicated in the treatment of infections caused by susce…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062298
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 |
|---|---|---|---|---|
| Ery-Taberythromycin | Erythromycin 500 mg/1 | Tablet, Delayed releaseOral | Arbor Pharmaceuticals, Inc. | 24338-126 |
| Ery-Taberythromycin | Erythromycin 250 mg/1 | Tablet, Delayed releaseOral | Arbor Pharmaceuticals, Inc. | 24338-122 |
| Ery-Taberythromycin | Erythromycin 333 mg/1 | Tablet, Delayed releaseOral | Arbor Pharmaceuticals, Inc. | 24338-124 |
| Erythromycin | Erythromycin 250 mg/1 | Tablet, Delayed releaseOral | Wilshire Pharmaceuticals | 52536-180 |
| Erythromycin | Erythromycin 500 mg/1 | Tablet, Delayed releaseOral | Wilshire Pharmaceuticals | 52536-186 |