Prescription drug · ANDA
Clarithromycin NDC 50090-5282
Clarithromycin 500 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5282-0 | 50090528200 | 20 TABLET in 1 BOTTLE (50090-5282-0)Marketed from Oct 22, 2020 | |
| 50090-5282-1 | 50090528201 | 30 TABLET in 1 BOTTLE (50090-5282-1)Marketed from Oct 22, 2020 | |
| 50090-5282-2 | 50090528202 | 14 TABLET in 1 BOTTLE (50090-5282-2)Marketed from Oct 22, 2020 | |
| 50090-5282-3 | 50090528203 | 28 TABLET in 1 BOTTLE (50090-5282-3)Marketed from Dec 11, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065136
- 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 50090-5282_81455578-b702-45f6-b99c-22968f4a4f38SPL ID 81455578-b702-45f6-b99c-22968f4a4f38SPL set ID adba78c2-9e51-4bed-8c6a-6f977f79c40cRxCUI 197517UNII 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
N450090528200followed by a unit qualifier and the quantityPackage 50090-5282-00. 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 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 ) • Pharyngitis/Tonsillitis ( 1.4 ) • Uncomplicated Skin and Skin Structure Infections ( 1.5 ) • Acute Otitis Media in Pediatric Patients ( 1.6 ) • Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7 ) • Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults ( 1.8 ) Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of cla…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065136
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 | TabletOral | Sandoz Inc | 0781-1962 |
| Clarithromycin | Clarithromycin 500 mg/1 | TabletOral | Coupler LLC | 67046-1515 |
| Clarithromycin | Clarithromycin 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1493 |
| Clarithromycin | Clarithromycin 500 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-668 |
| Clarithromycin | Clarithromycin 500 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-051 |
| Clarithromycin | Clarithromycin 500 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-530 |
| Clarithromycin | Clarithromycin 500 mg/1 | TabletOral | DirectRx | 72189-299 |
| Clarithromycin | Clarithromycin 500 mg/1 | TabletOral | Proficient Rx LP | 82804-069 |