Prescription drug · ANDA

Clarithromycin NDC 50268-179

Clarithromycin 500 mg/1 · Tablet, Film coated · Oral · AvPAK

NDC codes

FDA NDC Directory
Product NDC (as listed)50268-179Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0179Add 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
50268-179-135026801791330 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-179-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-179-11)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 — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
AvPAK
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 50268-179_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

N450268017913 followed by a unit qualifier and the quantity

Package 50268-0179-13. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065489

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

FDA NDC Directory listings under ANDA 065489
ProductStrengthForm · routeLabelerProduct NDC
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8480
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-823
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralProficient Rx LP82804-141
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1830
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-225
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-226
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0927
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6872
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-044
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0017
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-045
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-085
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralAvPAK50268-178
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralAmerican Health Packaging68002-104
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0204
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralSportpharm LLC85766-202
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralSportpharm LLC85766-203
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5045
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralProficient Rx LP63187-625
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralDirect_Rx72189-639

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Clarithromycin NDC 50268-179 | Med-Code