Prescription drug · ANDA
Clarithromycin NDC 72189-299
Clarithromycin 500 mg/1 · Tablet · Oral · DirectRx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-299-10 | 72189029910 | 10 TABLET in 1 BOTTLE (72189-299-10)Marketed from Dec 2, 2021 | |
| 72189-299-20 | 72189029920 | 20 TABLET in 1 BOTTLE (72189-299-20)Marketed from Dec 2, 2021 | |
| 72189-299-28 | 72189029928 | 28 TABLET in 1 BOTTLE (72189-299-28)Marketed from Dec 2, 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
- Route
- Oral
- Labeler
- DirectRx
- 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 72189-299_2c2941fa-11d7-9f72-e063-6394a90af886SPL ID 2c2941fa-11d7-9f72-e063-6394a90af886SPL set ID d22bd12c-737b-4aab-e053-2995a90aff60RxCUI 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
N472189029910followed by a unit qualifier and the quantityPackage 72189-0299-10. 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)
1.1 Acute Bacterial Exacerbation of Chronic Bronchitis Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)]. 1.2 Acute Maxillary Sinusitis Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)]. 1.3 Community-Acquired Pneumonia Clarithromycin tablets are indicated [see Indications and Usage (1.9)] for t…
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 | A-S Medication Solutions | 50090-5282 |
| 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 | Proficient Rx LP | 82804-069 |