clarithromycin

Generic: clarithromycin

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarithromycin
Generic Name clarithromycin
Labeler sandoz inc
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

clarithromycin 125 mg/5mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-6022
Product ID 0781-6022_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065283
Listing Expiration 2026-12-31
Marketing Start 2007-09-04

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 07816022
Hyphenated Format 0781-6022

Supplemental Identifiers

RxCUI
240741 309322
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 ANDA065283 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (0781-6022-46)
  • 50 mL in 1 BOTTLE (0781-6022-52)
source: ndc

Packages (2)

0781-6022-46 100 mL in 1 BOTTLE (0781-6022-46) 0781-6022-52 50 mL in 1 BOTTLE (0781-6022-52)

Ingredients (1)

clarithromycin (125 mg/5mL)

Linked Drug Pages (1)

Clarithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "unii": ["H1250JIK0A"], "rxcui": ["240741", "309322"], "spl_set_id": ["22457862-0f88-4be8-b507-1c8f264269f2"], "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": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (0781-6022-46)", "package_ndc": "0781-6022-46", "marketing_start_date": "20070904"}, {"sample": false, "description": "50 mL in 1 BOTTLE (0781-6022-52)", "package_ndc": "0781-6022-52", "marketing_start_date": "20070904"}], "brand_name": "Clarithromycin", "product_id": "0781-6022_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Macrolide Antimicrobial [EPC]", "Macrolides [CS]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0781-6022", "generic_name": "Clarithromycin", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clarithromycin", "active_ingredients": [{"name": "CLARITHROMYCIN", "strength": "125 mg/5mL"}], "application_number": "ANDA065283", "marketing_category": "ANDA", "marketing_start_date": "20070904", "listing_expiration_date": "20261231"}