Prescription drug · ANDA
Clarithromycin NDC 63187-376
Clarithromycin 500 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-376-14 | 63187037614 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-14)Marketed from Nov 7, 2025 | |
| 63187-376-20 | 63187037620 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-20)Marketed from Dec 29, 2021 | |
| 63187-376-28 | 63187037628 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-28)Marketed from Sep 1, 2016 | |
| 63187-376-30 | 63187037630 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-30)Marketed from Sep 1, 2016 | |
| 63187-376-60 | 63187037660 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-60)Marketed from Sep 1, 2016 | |
| 63187-376-90 | 63187037690 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-90)Marketed from Dec 29, 2021 |
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 203584
- 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 63187-376_f6ee6e86-2078-4354-9def-3f94fc7b6a6cSPL ID f6ee6e86-2078-4354-9def-3f94fc7b6a6cSPL set ID 9eb306e0-ccfb-418c-82ca-204f20a788f7RxCUI 197517UNII H1250JIK0AUPC 0363187376208
- 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
N463187037614followed by a unit qualifier and the quantityPackage 63187-0376-14. 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 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 not available at present). Acu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203584
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 | Lannett Company, Inc. | 0527-1932 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Solaris Pharma Corporation | 73473-909 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Solaris Pharma Corporation | 73473-910 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-435 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-752 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Lannett Company, Inc. | 0527-1931 |