Prescription drug · ANDA
Clarithromycin NDC 50268-178
Clarithromycin 250 mg/1 · Tablet, Film coated · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-178-15 | 5026801781550268017815 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-178-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-178-11)Marketed from Oct 10, 2016 |
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
- AvPAKNDC labeler code 50268
- 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 50268-178_4a8fd333-72f9-4fae-e063-6394a90af77eSPL ID 4a8fd333-72f9-4fae-e063-6394a90af77eSPL set ID 1920f943-bbf1-cfd9-7475-96a35680a9e0RxCUI 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
N450268017815followed by a unit qualifier and the quantityPackage 50268-0178-15. 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 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 …
Excerpt only. Read the full label for complete information.
About NDC 50268-178
- What is NDC 50268-178?
- 50268-178 is the product NDC for Clarithromycin, Clarithromycin 250 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, 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?
- AvPAK, NDC labeler code 50268. 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 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 | Aurobindo Pharma Limited | 65862-226 |
| 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 |