Clarithromycin NDC 0527-1930

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-1930Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-1930Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0527-1930-06	00527193006	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0527-1930-06)Marketed from Sep 10, 2019

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 — 500 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Lannett Company, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208987
Marketing start: Sep 10, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Macrolides (Chemical structure)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0527-1930_05ef280b-60a9-77ec-e063-6394a90a7821SPL ID 05ef280b-60a9-77ec-e063-6394a90a7821SPL set ID 71a836d0-d60f-6418-e053-2a95a90aa6efRxCUI 359385UNII H1250JIK0AUPC 0305271930064
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

N400527193006 followed by a unit qualifier and the quantity

Package 00527-1930-06. 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 Sep 22, 2023.

Indications (excerpt from the label)

Clarithromycin extended-release tablets 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) Limitations of Use Clarithromycin extended-release tablets are indicated only for acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, and community-acquired pneumonia in adults. (1.9) To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets and other antibacterial drugs, clarithromycin extended-r…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208987

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208987
Product	Strength	Form · route	Labeler	Product NDC
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coated, Extended releaseOral	Solaris Pharma Corporation	73473-911
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coated, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	43063-942
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coated, Extended releaseOral	Chartwell RX, LLC	62135-883