Prescription drug · ANDA
Clarithromycin NDC 73473-911
Clarithromycin 500 mg/1 · Tablet, Film coated, Extended release · Oral · Solaris Pharma Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73473-911-60 | 73473091160 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (73473-911-60)Marketed from Sep 10, 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)
- Clarithromycin
- Generic name (nonproprietary)
- clarithromycin
- Active ingredients
- Clarithromycin — 500 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Solaris Pharma Corporation
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208987
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Macrolides (Chemical structure)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 73473-911_4d4303a8-74ef-6e98-e063-6394a90a47d6SPL ID 4d4303a8-74ef-6e98-e063-6394a90a47d6SPL set ID 4d4303f8-88dd-8b88-e063-6394a90ab48fRxCUI 359385UNII H1250JIK0A
- Pharmacologic class
- Macrolide Antimicrobial
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
N473473091160followed by a unit qualifier and the quantityPackage 73473-0911-60. 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)
Clarithromycin extended-release tablets is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Limitations of Use Clarithromycin extended-release tablets are indicated only for acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, and community-acquired pneumonia in adults. (1.9) To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets and other antibacterial drugs, clarithromycin extended-r…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208987
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 |
|---|---|---|---|---|
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-942 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coated, Extended releaseOral | Chartwell RX, LLC | 62135-883 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coated, Extended releaseOral | Lannett Company, Inc. | 0527-1930 |