Prescription drug · ANDA
Clarithromycin NDC 85766-197
Clarithromycin 250 mg/1 · Tablet, Film coated · Oral · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-197-01 | 85766019701 | 100 TABLET, FILM COATED in 1 BOTTLE (85766-197-01)Marketed from Apr 17, 2026 | |
| 85766-197-05 | 85766019705 | 5 TABLET, FILM COATED in 1 BOTTLE (85766-197-05)Marketed from Apr 17, 2026 | |
| 85766-197-07 | 85766019707 | 7 TABLET, FILM COATED in 1 BOTTLE (85766-197-07)Marketed from Apr 17, 2026 | |
| 85766-197-10 | 85766019710 | 10 TABLET, FILM COATED in 1 BOTTLE (85766-197-10)Marketed from Apr 17, 2026 | |
| 85766-197-15 | 85766019715 | 15 TABLET, FILM COATED in 1 BOTTLE (85766-197-15)Marketed from Apr 17, 2026 | |
| 85766-197-20 | 85766019720 | 20 TABLET, FILM COATED in 1 BOTTLE (85766-197-20)Marketed from Apr 17, 2026 | |
| 85766-197-30 | 85766019730 | 30 TABLET, FILM COATED in 1 BOTTLE (85766-197-30)Marketed from Apr 17, 2026 | |
| 85766-197-60 | 85766019760 | 60 TABLET, FILM COATED in 1 BOTTLE (85766-197-60)Marketed from Apr 17, 2026 | |
| 85766-197-90 | 85766019790 | 90 TABLET, FILM COATED in 1 BOTTLE (85766-197-90)Marketed from Apr 17, 2026 |
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 — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sportpharm LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210459
- 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 85766-197_4fa17015-6060-4973-e063-6394a90a798dSPL ID 4fa17015-6060-4973-e063-6394a90a798dSPL set ID de33ba3a-9df1-4076-8d5f-b603d2698096RxCUI 197516, 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
N485766019701followed by a unit qualifier and the quantityPackage 85766-0197-01. 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 210459
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 | Sportpharm LLC | 85766-198 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-344 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-345 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-345 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-344 |