NDC codes

FDA NDC Directory
Product NDC (as listed)85766-198Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85766-0198Add 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
85766-198-018576601980185766019801100 TABLET, FILM COATED in 1 BOTTLE (85766-198-01)Marketed from Apr 17, 2026
85766-198-0585766019805857660198055 TABLET, FILM COATED in 1 BOTTLE (85766-198-05)Marketed from Apr 17, 2026
85766-198-0785766019807857660198077 TABLET, FILM COATED in 1 BOTTLE (85766-198-07)Marketed from Apr 17, 2026
85766-198-10857660198108576601981010 TABLET, FILM COATED in 1 BOTTLE (85766-198-10)Marketed from Apr 17, 2026
85766-198-15857660198158576601981515 TABLET, FILM COATED in 1 BOTTLE (85766-198-15)Marketed from Apr 17, 2026
85766-198-20857660198208576601982020 TABLET, FILM COATED in 1 BOTTLE (85766-198-20)Marketed from Apr 17, 2026
85766-198-30857660198308576601983030 TABLET, FILM COATED in 1 BOTTLE (85766-198-30)Marketed from Apr 17, 2026
85766-198-60857660198608576601986060 TABLET, FILM COATED in 1 BOTTLE (85766-198-60)Marketed from Apr 17, 2026
85766-198-90857660198908576601989090 TABLET, FILM COATED in 1 BOTTLE (85766-198-90)Marketed from Apr 17, 2026

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
Route
Oral
Labeler
Sportpharm LLCNDC labeler code 85766
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210459
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 85766-198_4fa17015-6060-4973-e063-6394a90a798dSPL ID 4fa17015-6060-4973-e063-6394a90a798dSPL set ID de33ba3a-9df1-4076-8d5f-b603d2698096RxCUI 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

N485766019801 followed by a unit qualifier and the quantity

Package 85766-0198-01. 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 tablets are 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 clarithrom…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85766-198

What is NDC 85766-198?
85766-198 is the product NDC for Clarithromycin, Clarithromycin 500 mg/1 tablet, film coated, listed with the FDA by Sportpharm LLC. It has 9 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?
Sportpharm LLC, NDC labeler code 85766. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Clarithromycin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralAmerican Health Packaging68002-10468002-0104-04
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-08582868-0085-2082868-0085-30
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralDirect_Rx72189-63972189-0639-1072189-0639-20
ClarithromycinClarithromycin 500 mg/1TabletOralCoupler LLC67046-151567046-1515-03
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-848068788-8480-0268788-8480-08
ClarithromycinClarithromycin 500 mg/1TabletOralNorthwind Health Company, LLC51655-66851655-0668-2051655-0668-52
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-34446708-0344-3046708-0344-6046708-0344-91
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-34546708-0345-3046708-0345-6046708-0345-91
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-34462332-0344-3062332-0344-6062332-0344-91
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-34562332-0345-3062332-0345-6062332-0345-91

All 54 Clarithromycin NDCs

Other NDCs under ANDA 210459

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

FDA NDC Directory listings under ANDA 210459
ProductStrengthForm · routeLabelerProduct NDC
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-344
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-345
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-344
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-345
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralSportpharm LLC85766-197

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