clarithromycin

Generic: clarithromycin

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarithromycin
Generic Name clarithromycin
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clarithromycin 500 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1515
Product ID 67046-1515_2d6d01fe-a7b9-cbff-e063-6294a90a6bca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065136
Listing Expiration 2026-12-31
Marketing Start 2025-02-05

Pharmacologic Class

Established (EPC)
macrolide antimicrobial [epc]
Mechanism of Action
cytochrome p450 3a4 inhibitors [moa] cytochrome p450 3a inhibitors [moa] p-glycoprotein inhibitors [moa]
Chemical Structure
macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461515
Hyphenated Format 67046-1515

Supplemental Identifiers

RxCUI
197517
UNII
H1250JIK0A
NUI
N0000175935 M0028311 N0000182141 N0000190114 N0000185503

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name clarithromycin (source: ndc)
Generic Name clarithromycin (source: ndc)
Application Number ANDA065136 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1515-3)
source: ndc

Packages (1)

67046-1515-3 30 TABLET in 1 BLISTER PACK (67046-1515-3)

Ingredients (1)

clarithromycin (500 mg/1)

Linked Drug Pages (1)

Clarithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d6d01fe-a7b9-cbff-e063-6294a90a6bca", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "unii": ["H1250JIK0A"], "rxcui": ["197517"], "spl_set_id": ["2d6cfd87-9b8c-bba9-e063-6294a90aff5a"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_epc": ["Macrolide Antimicrobial [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1515-3)", "package_ndc": "67046-1515-3", "marketing_start_date": "20250205"}], "brand_name": "Clarithromycin", "product_id": "67046-1515_2d6d01fe-a7b9-cbff-e063-6294a90a6bca", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Macrolide Antimicrobial [EPC]", "Macrolides [CS]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "67046-1515", "generic_name": "Clarithromycin", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clarithromycin", "active_ingredients": [{"name": "CLARITHROMYCIN", "strength": "500 mg/1"}], "application_number": "ANDA065136", "marketing_category": "ANDA", "marketing_start_date": "20250205", "listing_expiration_date": "20261231"}