clarithromycin

Generic: clarithromycin

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarithromycin
Generic Name clarithromycin
Labeler a-s medication solutions
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

clarithromycin 250 mg/5mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-0994
Product ID 50090-0994_b17c8e0b-5db9-4116-9073-8e8fac3459dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065283
Listing Expiration 2027-12-31
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 500900994
Hyphenated Format 50090-0994

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 50 mL in 1 BOTTLE (50090-0994-0)
source: ndc

Packages (1)

50090-0994-0 50 mL in 1 BOTTLE (50090-0994-0)

Ingredients (1)

clarithromycin (250 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": "b17c8e0b-5db9-4116-9073-8e8fac3459dc", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "unii": ["H1250JIK0A"], "rxcui": ["309322"], "spl_set_id": ["fad1e5a3-59f9-4868-9937-d3b061ab8f00"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BOTTLE (50090-0994-0)", "package_ndc": "50090-0994-0", "marketing_start_date": "20141128"}], "brand_name": "Clarithromycin", "product_id": "50090-0994_b17c8e0b-5db9-4116-9073-8e8fac3459dc", "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": "50090-0994", "generic_name": "Clarithromycin", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clarithromycin", "active_ingredients": [{"name": "CLARITHROMYCIN", "strength": "250 mg/5mL"}], "application_number": "ANDA065283", "marketing_category": "ANDA", "marketing_start_date": "20070904", "listing_expiration_date": "20271231"}