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
Routes
ORAL
Active Ingredients

clarithromycin 250 mg/1

Manufacturer
Chartwell RX, LLC.

Identifiers & Regulatory

Product NDC 62135-616
Product ID 62135-616_f08573c8-02d4-3717-e053-2a95a90a2dda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065384
Listing Expiration 2026-12-31
Marketing Start 2007-08-20

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 62135616
Hyphenated Format 62135-616

Supplemental Identifiers

RxCUI
197516 197517
UPC
0362135615604 0362135616601
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 ANDA065384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-616-60)
source: ndc

Packages (1)

62135-616-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-616-60)

Ingredients (1)

clarithromycin (250 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": "f08573c8-02d4-3717-e053-2a95a90a2dda", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "upc": ["0362135615604", "0362135616601"], "unii": ["H1250JIK0A"], "rxcui": ["197516", "197517"], "spl_set_id": ["99d2fd6b-39ca-42f9-ad06-30e7fbc22c47"], "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 in 1 BOTTLE, PLASTIC (62135-616-60)", "package_ndc": "62135-616-60", "marketing_start_date": "20210201"}], "brand_name": "CLARITHROMYCIN", "product_id": "62135-616_f08573c8-02d4-3717-e053-2a95a90a2dda", "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": "62135-616", "generic_name": "Clarithromycin", "labeler_name": "Chartwell RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLARITHROMYCIN", "active_ingredients": [{"name": "CLARITHROMYCIN", "strength": "250 mg/1"}], "application_number": "ANDA065384", "marketing_category": "ANDA", "marketing_start_date": "20070820", "listing_expiration_date": "20261231"}