NDC codes

FDA NDC Directory
Product NDC (as listed)57237-045Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57237-0045Add 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
57237-045-60572370045605723700456060 TABLET, FILM COATED in 1 BOTTLE (57237-045-60)Marketed from Jul 25, 2012

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
Rising Pharma Holdings, Inc.NDC labeler code 57237
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 57237-045_ce30a7ce-c4f2-41b3-966d-c79fab80f76bSPL ID ce30a7ce-c4f2-41b3-966d-c79fab80f76bSPL set ID 0c4db97f-f4c9-4cac-9f12-9db1d967ebebRxCUI 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

N457237004560 followed by a unit qualifier and the quantity

Package 57237-0045-60. 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 clarithromycin tablets and…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57237-045

What is NDC 57237-045?
57237-045 is the product NDC for Clarithromycin, Clarithromycin 500 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, 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?
Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 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 coatedOralMajor Pharmaceuticals0904-6872
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-823
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0927
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1830
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralAvPAK50268-178
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralAvPAK50268-179
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-044
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralProficient Rx LP63187-625
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-225
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-226
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralAmerican Health Packaging68002-104
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5045
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8480
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0204
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0017
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralDirect_Rx72189-639
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralProficient Rx LP82804-141
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-085
ClarithromycinClarithromycin 250 mg/1Tablet, Film coatedOralSportpharm LLC85766-202
ClarithromycinClarithromycin 500 mg/1Tablet, Film coatedOralSportpharm LLC85766-203

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