What is NDC 76420-051?

76420-051 is the product NDC for Clarithromycin, Clarithromycin 500 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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 76420-051 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-051Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0051Add 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
76420-051-14	7642000511476420005114	14 TABLET in 1 BOTTLE (76420-051-14)Marketed from Oct 20, 2020
76420-051-20	7642000512076420005120	20 TABLET in 1 BOTTLE (76420-051-20)Marketed from Oct 20, 2020

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
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065136
Marketing start: Aug 25, 2005
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Macrolides (Chemical structure)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 76420-051_b21449e8-c203-520d-e053-2995a90ad298SPL ID b21449e8-c203-520d-e053-2995a90ad298SPL set ID a12e4d38-e0f8-4467-a26c-bb25a342aa92RxCUI 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

N476420005114 followed by a unit qualifier and the quantity

Package 76420-0051-14. 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 Oct 20, 2020.

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 clarithromycin tabl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-051

What is NDC 76420-051?: 76420-051 is the product NDC for Clarithromycin, Clarithromycin 500 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 2 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?: Asclemed USA, Inc., NDC labeler code 76420. 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	Sandoz Inc	0781-1962
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	Proficient Rx LP	82804-069