Prescription drug · ANDA
Clarithromycin NDC 43063-823
Clarithromycin 500 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-823-20 | 43063082320 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-20)Marketed from Jan 8, 2018 | |
| 43063-823-28 | 43063082328 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-28)Marketed from Feb 22, 2018 |
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
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065489
- 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 43063-823_3ba20925-0d1d-3712-e063-6394a90aa41bSPL ID 3ba20925-0d1d-3712-e063-6394a90aa41bSPL set ID ba216276-b0bd-420a-9e0d-090bdfcc2460RxCUI 197517UNII H1250JIK0AUPC 0343063823200
- 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
N443063082320followed by a unit qualifier and the quantityPackage 43063-0823-20. 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 tablets are 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 clarithrom…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065489
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 coatedOral | Preferred Pharmaceuticals Inc. | 68788-8480 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-141 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1830 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-225 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-226 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0927 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6872 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-044 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0017 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-045 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-085 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-178 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-179 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68002-104 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0204 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-202 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-203 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5045 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-625 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-639 |