clarithromycin

Generic: clarithromycin

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarithromycin
Generic Name clarithromycin
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

clarithromycin 500 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3116
Product ID 68071-3116_2abbae2e-2b8b-62d9-e063-6394a90a39b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203584
Listing Expiration 2026-12-31
Marketing Start 2015-12-04

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 680713116
Hyphenated Format 68071-3116

Supplemental Identifiers

RxCUI
197517
UPC
0368071311686
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 ANDA203584 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (68071-3116-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68071-3116-3)
  • 14 TABLET, FILM COATED in 1 BOTTLE (68071-3116-4)
  • 28 TABLET, FILM COATED in 1 BOTTLE (68071-3116-8)
source: ndc

Packages (4)

68071-3116-2 20 TABLET, FILM COATED in 1 BOTTLE (68071-3116-2) 68071-3116-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-3116-3) 68071-3116-4 14 TABLET, FILM COATED in 1 BOTTLE (68071-3116-4) 68071-3116-8 28 TABLET, FILM COATED in 1 BOTTLE (68071-3116-8)

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": "2abbae2e-2b8b-62d9-e063-6394a90a39b0", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "upc": ["0368071311686"], "unii": ["H1250JIK0A"], "rxcui": ["197517"], "spl_set_id": ["4a3febd5-8cf4-5306-e054-00144ff8d46c"], "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": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68071-3116-2)", "package_ndc": "68071-3116-2", "marketing_start_date": "20170308"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-3116-3)", "package_ndc": "68071-3116-3", "marketing_start_date": "20170308"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (68071-3116-4)", "package_ndc": "68071-3116-4", "marketing_start_date": "20170308"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (68071-3116-8)", "package_ndc": "68071-3116-8", "marketing_start_date": "20170308"}], "brand_name": "Clarithromycin", "product_id": "68071-3116_2abbae2e-2b8b-62d9-e063-6394a90a39b0", "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": "68071-3116", "generic_name": "Clarithromycin", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clarithromycin", "active_ingredients": [{"name": "CLARITHROMYCIN", "strength": "500 mg/1"}], "application_number": "ANDA203584", "marketing_category": "ANDA", "marketing_start_date": "20151204", "listing_expiration_date": "20261231"}