Prescription drug · ANDA
Clarithromycin NDC 0781-6023
Clarithromycin 250 mg/5mL · For suspension · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-6023-46 | 00781602346 | 100 mL in 1 BOTTLE (0781-6023-46)Marketed from Sep 4, 2007 | |
| 0781-6023-52 | 00781602352 | 50 mL in 1 BOTTLE (0781-6023-52)Marketed from Sep 4, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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/5mL
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065283
- 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 0781-6023_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbcSPL ID fcbab0c3-9fdb-40aa-9a17-e53f88a19bbcSPL set ID 22457862-0f88-4be8-b507-1c8f264269f2RxCUI 240741, 309322UNII 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
N400781602346followed by a unit qualifier and the quantityPackage 00781-6023-46. 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 is 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 ) Limitations of Use: To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used onl…
Excerpt only. Read the full label for complete information.
About NDC 0781-6023
- What is NDC 0781-6023?
- 0781-6023 is the product NDC for Clarithromycin, Clarithromycin 250 mg/5mL for suspension, listed with the FDA by Sandoz Inc. It has 2 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?
- Sandoz Inc, NDC labeler code 0781. 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 | Sportpharm LLC | 85766-197 | 85766-0197-0185766-0197-0585766-0197-07+6 more |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-198 | 85766-0198-0185766-0198-0585766-0198-07+6 more |
| Clarithromycin | Clarithromycin 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-345 | 62332-0345-3062332-0345-6062332-0345-91 |
| Clarithromycin | Clarithromycin 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-344 | 62332-0344-3062332-0344-6062332-0344-91 |
Other NDCs under ANDA 065283
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 125 mg/5mL | For suspensionOral | Sandoz Inc | 0781-6022 |
| Clarithromycin | Clarithromycin 250 mg/5mL | For suspensionOral | A-S Medication Solutions | 50090-0994 |