clarithromycin

Generic: clarithromycin

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

clarithromycin 500 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-179
Product ID 50268-179_4a8fd333-72f9-4fae-e063-6394a90af77e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065489
Listing Expiration 2027-12-31
Marketing Start 2016-10-10

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 50268179
Hyphenated Format 50268-179

Supplemental Identifiers

RxCUI
197516 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
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-179-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-179-11)
source: ndc

Packages (1)

50268-179-13 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-179-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-179-11)

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": "4a8fd333-72f9-4fae-e063-6394a90af77e", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "unii": ["H1250JIK0A"], "rxcui": ["197516", "197517"], "spl_set_id": ["1920f943-bbf1-cfd9-7475-96a35680a9e0"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-179-13)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-179-11)", "package_ndc": "50268-179-13", "marketing_start_date": "20161010"}], "brand_name": "Clarithromycin", "product_id": "50268-179_4a8fd333-72f9-4fae-e063-6394a90af77e", "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": "50268-179", "generic_name": "Clarithromycin", "labeler_name": "AvPAK", "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": "20161010", "listing_expiration_date": "20271231"}