clarithromycin

Generic: clarithromycin

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarithromycin
Generic Name clarithromycin
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

clarithromycin 500 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-639
Product ID 72189-639_3e4be100-cd38-4560-e063-6294a90a9328
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065489
Listing Expiration 2026-12-31
Marketing Start 2025-08-05

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 72189639
Hyphenated Format 72189-639

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 ANDA065489 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (72189-639-10)
  • 20 TABLET, FILM COATED in 1 BOTTLE (72189-639-20)
source: ndc

Packages (2)

72189-639-10 10 TABLET, FILM COATED in 1 BOTTLE (72189-639-10) 72189-639-20 20 TABLET, FILM COATED in 1 BOTTLE (72189-639-20)

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": "3e4be100-cd38-4560-e063-6294a90a9328", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "unii": ["H1250JIK0A"], "rxcui": ["197517"], "spl_set_id": ["3ba1da51-ba5b-323f-e063-6294a90a0333"], "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": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (72189-639-10)", "package_ndc": "72189-639-10", "marketing_start_date": "20250805"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (72189-639-20)", "package_ndc": "72189-639-20", "marketing_start_date": "20250805"}], "brand_name": "Clarithromycin", "product_id": "72189-639_3e4be100-cd38-4560-e063-6294a90a9328", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Macrolide Antimicrobial [EPC]", "Macrolides [CS]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "72189-639", "generic_name": "Clarithromycin", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clarithromycin", "active_ingredients": [{"name": "CLARITHROMYCIN", "strength": "500 mg/1"}], "application_number": "ANDA065489", "marketing_category": "ANDA", "marketing_start_date": "20250805", "listing_expiration_date": "20261231"}