NDC codes

FDA NDC Directory
Product NDC (as listed)43063-942Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0942Add 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 NDC11-digit (billing)PackageCopy
43063-942-144306309421414 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-942-14)Marketed from Sep 10, 2019

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, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208987
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 43063-942_415eafd4-5d9c-7a6d-e063-6294a90a0f28SPL ID 415eafd4-5d9c-7a6d-e063-6294a90a0f28SPL set ID 1d328f5d-73c1-4df7-a3df-71d0e0221181RxCUI 359385UNII 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

N443063094214 followed by a unit qualifier and the quantity

Package 43063-0942-14. 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 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
ProductStrengthForm · routeLabelerProduct NDC
ClarithromycinClarithromycin 500 mg/1Tablet, Film coated, Extended releaseOralSolaris Pharma Corporation73473-911
ClarithromycinClarithromycin 500 mg/1Tablet, Film coated, Extended releaseOralChartwell RX, LLC62135-883
ClarithromycinClarithromycin 500 mg/1Tablet, Film coated, Extended releaseOralLannett Company, Inc.0527-1930

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in