clarithromycin

Generic: clarithromycin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarithromycin
Generic Name clarithromycin
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

clarithromycin 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-226
Product ID 65862-226_4bb3048c-0a75-4818-9be5-4c81cfe9649c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065489
Listing Expiration 2026-12-31
Marketing Start 2012-07-25

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 65862226
Hyphenated Format 65862-226

Supplemental Identifiers

RxCUI
197516 197517
UNII
H1250JIK0A
NUI
N0000175935 M0028311 N0000182141 N0000190114 N0000185503

Packaging Origin

Original Packager
true

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 BLISTER PACK in 1 CARTON (65862-226-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 60 TABLET, FILM COATED in 1 BOTTLE (65862-226-60)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-226-99)
source: ndc

Packages (3)

65862-226-10 10 BLISTER PACK in 1 CARTON (65862-226-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-226-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-226-60) 65862-226-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-226-99)

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": "4bb3048c-0a75-4818-9be5-4c81cfe9649c", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "unii": ["H1250JIK0A"], "rxcui": ["197516", "197517"], "spl_set_id": ["9aaffb41-408c-4372-8fd5-1d649450c0e9"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-226-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-226-10", "marketing_start_date": "20120725"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65862-226-60)", "package_ndc": "65862-226-60", "marketing_start_date": "20120725"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-226-99)", "package_ndc": "65862-226-99", "marketing_start_date": "20120725"}], "brand_name": "Clarithromycin", "product_id": "65862-226_4bb3048c-0a75-4818-9be5-4c81cfe9649c", "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": "65862-226", "generic_name": "Clarithromycin", "labeler_name": "Aurobindo Pharma Limited", "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": "20120725", "listing_expiration_date": "20261231"}