What is NDC 46708-344?

46708-344 is the product NDC for Clarithromycin, Clarithromycin 250 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-344 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-344Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0344Add 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
46708-344-30	4670803443046708034430	30 TABLET, FILM COATED in 1 BOTTLE (46708-344-30)Marketed from Feb 1, 2022
46708-344-60	4670803446046708034460	60 TABLET, FILM COATED in 1 BOTTLE (46708-344-60)Marketed from Feb 1, 2022
46708-344-91	4670803449146708034491	1000 TABLET, FILM COATED in 1 BOTTLE (46708-344-91)Marketed from Feb 1, 2022

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 — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210459
Marketing start: Feb 1, 2022
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 46708-344_17817dba-4183-4a14-a55f-3e1240ea03a1SPL ID 17817dba-4183-4a14-a55f-3e1240ea03a1SPL set ID 268d21f9-02c9-41b0-9487-7968ea12720dRxCUI 197516, 197517UNII H1250JIK0AUPC 0346708344306
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

N446708034430 followed by a unit qualifier and the quantity

Package 46708-0344-30. 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 29, 2023.

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 clarithrom…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-344

What is NDC 46708-344?: 46708-344 is the product NDC for Clarithromycin, Clarithromycin 250 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 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
Clarithromycin	Clarithromycin 250 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-197	85766-0197-0185766-0197-0585766-0197-07+6 more

All 54 Clarithromycin NDCs

Other NDCs under ANDA 210459

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

FDA NDC Directory listings under ANDA 210459
Product	Strength	Form · route	Labeler	Product NDC
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-345
Clarithromycin	Clarithromycin 250 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-344
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-345
Clarithromycin	Clarithromycin 250 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-197
Clarithromycin	Clarithromycin 500 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-198