Prescription drug · ANDA
Clarithromycin NDC 65862-226
Clarithromycin 500 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-226-10 | 6586202261065862022610 | 10 BLISTER PACK in 1 CARTON (65862-226-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 25, 2012 | |
| 65862-226-60 | 6586202266065862022660 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-226-60)Marketed from Jul 25, 2012 | |
| 65862-226-99 | 6586202269965862022699 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-226-99)Marketed from Jul 25, 2012 |
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
- Aurobindo Pharma LimitedNDC labeler code 65862
- 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 65862-226_4bb3048c-0a75-4818-9be5-4c81cfe9649cSPL ID 4bb3048c-0a75-4818-9be5-4c81cfe9649cSPL set ID 9aaffb41-408c-4372-8fd5-1d649450c0e9RxCUI 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
N465862022610followed by a unit qualifier and the quantityPackage 65862-0226-10. 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)
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.
About NDC 65862-226
- What is NDC 65862-226?
- 65862-226 is the product NDC for Clarithromycin, Clarithromycin 500 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clarithromycin.
- What is the active ingredient?
- Clarithromycin.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clarithromycin?
- 53 other product NDCs are listed under this name. See all Clarithromycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clarithromycin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68002-104 | 68002-0104-04 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-085 | 82868-0085-2082868-0085-30 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-639 | 72189-0639-1072189-0639-20 |
| Clarithromycin | Clarithromycin 500 mg/1 | TabletOral | Coupler LLC | 67046-1515 | 67046-1515-03 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8480 | 68788-8480-0268788-8480-08 |
| Clarithromycin | Clarithromycin 500 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-668 | 51655-0668-2051655-0668-52 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-344 | 46708-0344-3046708-0344-6046708-0344-91 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-345 | 46708-0345-3046708-0345-6046708-0345-91 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-344 | 62332-0344-3062332-0344-6062332-0344-91 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-345 | 62332-0345-3062332-0345-6062332-0345-91 |
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 | Major Pharmaceuticals | 0904-6872 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-823 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0927 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1830 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-178 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-179 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-044 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-045 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-625 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-225 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68002-104 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5045 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8480 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0204 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0017 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-639 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-141 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-085 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-202 |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-203 |