NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1493Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1493Add 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
71335-1493-1713351493017133514930120 TABLET in 1 BOTTLE (71335-1493-1)Marketed from Mar 5, 2020
71335-1493-2713351493027133514930214 TABLET in 1 BOTTLE (71335-1493-2)Marketed from Jul 22, 2020
71335-1493-3713351493037133514930330 TABLET in 1 BOTTLE (71335-1493-3)Marketed from Mar 5, 2020
71335-1493-4713351493047133514930421 TABLET in 1 BOTTLE (71335-1493-4)Marketed from Apr 7, 2022
71335-1493-5713351493057133514930528 TABLET in 1 BOTTLE (71335-1493-5)Marketed from Feb 25, 2020
71335-1493-6713351493067133514930660 TABLET in 1 BOTTLE (71335-1493-6)Marketed from May 11, 2021
71335-1493-7713351493077133514930790 TABLET in 1 BOTTLE (71335-1493-7)Marketed from Jul 1, 2021
71335-1493-8713351493087133514930810 TABLET in 1 BOTTLE (71335-1493-8)Marketed from Jun 1, 2020
71335-1493-97133514930971335149309180 TABLET in 1 BOTTLE (71335-1493-9)Marketed from Apr 7, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065136
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 71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5SPL ID 7b87c8aa-515f-4027-9c33-a91f080831d5SPL set ID 27e02b77-4332-49e0-8d0c-a072cf5dff92RxCUI 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

N471335149301 followed by a unit qualifier and the quantity

Package 71335-1493-01. 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 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 cla…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1493

What is NDC 71335-1493?
71335-1493 is the product NDC for Clarithromycin, Clarithromycin 500 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 065136

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

FDA NDC Directory listings under ANDA 065136
ProductStrengthForm · routeLabelerProduct NDC
ClarithromycinClarithromycin 500 mg/1TabletOralSandoz Inc0781-1962
ClarithromycinClarithromycin 500 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-530
ClarithromycinClarithromycin 500 mg/1TabletOralA-S Medication Solutions50090-5282
ClarithromycinClarithromycin 500 mg/1TabletOralNorthwind Health Company, LLC51655-668
ClarithromycinClarithromycin 500 mg/1TabletOralCoupler LLC67046-1515
ClarithromycinClarithromycin 500 mg/1TabletOralDirectRx72189-299
ClarithromycinClarithromycin 500 mg/1TabletOralAsclemed USA, Inc.76420-051
ClarithromycinClarithromycin 500 mg/1TabletOralProficient Rx LP82804-069

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