What is NDC 0781-1962?

0781-1962 is the product NDC for Clarithromycin, Clarithromycin 500 mg/1 tablet, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clarithromycin NDC 0781-1962 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-1962Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-1962Add 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 NDC	11-digit (billing)	Package	Copy
0781-1962-60	0078119626000781196260	60 TABLET in 1 BOTTLE (0781-1962-60)Marketed from Aug 25, 2005

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Route: Oral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065136
Marketing start: Aug 25, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Macrolides (Chemical structure)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0781-1962_a18fa357-b294-48b9-aabe-dad7d6259ba3SPL ID a18fa357-b294-48b9-aabe-dad7d6259ba3SPL set ID b98b02bb-2609-49a0-b29f-e5911aa0cbc1RxCUI 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

N400781196260 followed by a unit qualifier and the quantity

Package 00781-1962-60. 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 May 30, 2023.

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 0781-1962

What is NDC 0781-1962?: 0781-1962 is the product NDC for Clarithromycin, Clarithromycin 500 mg/1 tablet, listed with the FDA by Sandoz 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?: Sandoz Inc, NDC labeler code 0781. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	American Health Packaging	68002-104	68002-0104-04
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	82868-085	82868-0085-2082868-0085-30
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-639	72189-0639-1072189-0639-20
Clarithromycin	Clarithromycin 500 mg/1	TabletOral	Coupler LLC	67046-1515	67046-1515-03
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8480	68788-8480-0268788-8480-08
Clarithromycin	Clarithromycin 500 mg/1	TabletOral	Northwind Health Company, LLC	51655-668	51655-0668-2051655-0668-52
Clarithromycin	Clarithromycin 250 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-344	46708-0344-3046708-0344-6046708-0344-91
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-345	46708-0345-3046708-0345-6046708-0345-91
Clarithromycin	Clarithromycin 250 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-344	62332-0344-3062332-0344-6062332-0344-91
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-345	62332-0345-3062332-0345-6062332-0345-91

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
Product	Strength	Form · route	Labeler	Product NDC
Clarithromycin	Clarithromycin 500 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-530
Clarithromycin	Clarithromycin 500 mg/1	TabletOral	A-S Medication Solutions	50090-5282
Clarithromycin	Clarithromycin 500 mg/1	TabletOral	Northwind Health Company, LLC	51655-668
Clarithromycin	Clarithromycin 500 mg/1	TabletOral	Coupler LLC	67046-1515
Clarithromycin	Clarithromycin 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-1493
Clarithromycin	Clarithromycin 500 mg/1	TabletOral	DirectRx	72189-299
Clarithromycin	Clarithromycin 500 mg/1	TabletOral	Asclemed USA, Inc.	76420-051
Clarithromycin	Clarithromycin 500 mg/1	TabletOral	Proficient Rx LP	82804-069