Clarithromycin NDC 0527-1931

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-1931Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-1931Add 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
0527-1931-06	00527193106	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1931-06)Marketed from Nov 23, 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 — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Lannett Company, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203584
Marketing start: Nov 23, 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 0527-1931_0a136962-d1f1-f728-e063-6394a90a01b0SPL ID 0a136962-d1f1-f728-e063-6394a90a01b0SPL set ID 9bf207c0-86eb-4f3b-92e7-f65f3fccd5a7RxCUI 197516, 197517UNII H1250JIK0AUPC 0305271932068, 0305271931061
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

N400527193106 followed by a unit qualifier and the quantity

Package 00527-1931-06. 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 Nov 13, 2023.

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) 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 clarithromycin and other antibacter…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203584

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

FDA NDC Directory listings under ANDA 203584
Product	Strength	Form · route	Labeler	Product NDC
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Lannett Company, Inc.	0527-1932
Clarithromycin	Clarithromycin 250 mg/1	Tablet, Film coatedOral	Solaris Pharma Corporation	73473-909
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Solaris Pharma Corporation	73473-910
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-376
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-435
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-752