clarithromycin

Generic: clarithromycin

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarithromycin
Generic Name clarithromycin
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

clarithromycin 500 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-883
Product ID 62135-883_459c547f-8c37-1425-e063-6394a90a48e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208987
Listing Expiration 2026-12-31
Marketing Start 2019-09-10

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 62135883
Hyphenated Format 62135-883

Supplemental Identifiers

RxCUI
359385
UPC
0362135883607
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 ANDA208987 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-883-60)
source: ndc

Packages (1)

62135-883-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-883-60)

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": "459c547f-8c37-1425-e063-6394a90a48e6", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "upc": ["0362135883607"], "unii": ["H1250JIK0A"], "rxcui": ["359385"], "spl_set_id": ["dea5bd78-7f93-4bc4-a2e4-1b021f5fe098"], "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": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-883-60)", "package_ndc": "62135-883-60", "marketing_start_date": "20240416"}], "brand_name": "CLARITHROMYCIN", "product_id": "62135-883_459c547f-8c37-1425-e063-6394a90a48e6", "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": "62135-883", "generic_name": "CLARITHROMYCIN", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLARITHROMYCIN", "active_ingredients": [{"name": "CLARITHROMYCIN", "strength": "500 mg/1"}], "application_number": "ANDA208987", "marketing_category": "ANDA", "marketing_start_date": "20190910", "listing_expiration_date": "20261231"}