clarithromycin

Generic: clarithromycin

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarithromycin
Generic Name clarithromycin
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

clarithromycin 500 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2805
Product ID 0591-2805_d97b84fc-7e0b-4f73-804d-522c2448b058
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065145
Listing Expiration 2026-12-31
Marketing Start 2014-02-27

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 05912805
Hyphenated Format 0591-2805

Supplemental Identifiers

RxCUI
359385
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 ANDA065145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2805-60)
source: ndc

Packages (1)

0591-2805-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2805-60)

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": "d97b84fc-7e0b-4f73-804d-522c2448b058", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "unii": ["H1250JIK0A"], "rxcui": ["359385"], "spl_set_id": ["d5be5f12-6392-4d7d-ab23-ebc205ac1a85"], "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": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2805-60)", "package_ndc": "0591-2805-60", "marketing_start_date": "20140227"}], "brand_name": "clarithromycin", "product_id": "0591-2805_d97b84fc-7e0b-4f73-804d-522c2448b058", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Macrolide Antimicrobial [EPC]", "Macrolides [CS]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0591-2805", "generic_name": "clarithromycin", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "clarithromycin", "active_ingredients": [{"name": "CLARITHROMYCIN", "strength": "500 mg/1"}], "application_number": "ANDA065145", "marketing_category": "ANDA", "marketing_start_date": "20140227", "listing_expiration_date": "20261231"}