Prescription drug · ANDA
Clarithromycin NDC 63187-625
Clarithromycin 500 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-625-14 | 63187062514 | 14 TABLET, FILM COATED in 1 BOTTLE (63187-625-14)Marketed from Dec 1, 2018 | |
| 63187-625-28 | 63187062528 | 28 TABLET, FILM COATED in 1 BOTTLE (63187-625-28)Marketed from Dec 1, 2018 | |
| 63187-625-30 | 63187062530 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-625-30)Marketed from Dec 1, 2018 | |
| 63187-625-60 | 63187062560 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-625-60)Marketed from Dec 1, 2018 | |
| 63187-625-90 | 63187062590 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-625-90)Marketed from Dec 1, 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
- Proficient Rx LP
- 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 63187-625_5e3f6cab-81be-4dd4-adb7-02dc14c3ca53SPL ID 5e3f6cab-81be-4dd4-adb7-02dc14c3ca53SPL set ID b1bdf526-4f16-4130-b614-4cb678f060d7RxCUI 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
N463187062514followed by a unit qualifier and the quantityPackage 63187-0625-14. 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 Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below: Adults (Clarithromycin Tablets, USP) Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are …
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 | PD-Rx Pharmaceuticals, Inc. | 43063-823 |
| 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 | Direct_Rx | 72189-639 |