What is NDC 0591-2805?

0591-2805 is the product NDC for clarithromycin, Clarithromycin 500 mg/1 tablet, film coated, extended release, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. 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 0591-2805 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-2805Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-2805Add 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
0591-2805-60	0059128056000591280560	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2805-60)Marketed from Feb 27, 2014

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, Film coated, Extended release
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0591
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065145
Marketing start: Feb 27, 2014
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 0591-2805_88f7a9d4-36bb-49ff-a34c-ac34cc309e8eSPL ID 88f7a9d4-36bb-49ff-a34c-ac34cc309e8e
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

N400591280560 followed by a unit qualifier and the quantity

Package 00591-2805-60. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0591-2805

What is NDC 0591-2805?: 0591-2805 is the product NDC for clarithromycin, Clarithromycin 500 mg/1 tablet, film coated, extended release, listed with the FDA by Actavis Pharma, 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?: Actavis Pharma, Inc., NDC labeler code 0591. 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