clarithromycin

Generic: clarithromycin

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

clarithromycin 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-823
Product ID 43063-823_3ba20925-0d1d-3712-e063-6394a90aa41b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065489
Listing Expiration 2026-12-31
Marketing Start 2012-07-25

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 43063823
Hyphenated Format 43063-823

Supplemental Identifiers

RxCUI
197517
UPC
0343063823200
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 ANDA065489 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-20)
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-28)
source: ndc

Packages (2)

43063-823-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-20) 43063-823-28 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-28)

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": "3ba20925-0d1d-3712-e063-6394a90aa41b", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "upc": ["0343063823200"], "unii": ["H1250JIK0A"], "rxcui": ["197517"], "spl_set_id": ["ba216276-b0bd-420a-9e0d-090bdfcc2460"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-20)", "package_ndc": "43063-823-20", "marketing_start_date": "20180108"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-28)", "package_ndc": "43063-823-28", "marketing_start_date": "20180222"}], "brand_name": "Clarithromycin", "product_id": "43063-823_3ba20925-0d1d-3712-e063-6394a90aa41b", "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": "43063-823", "generic_name": "Clarithromycin", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clarithromycin", "active_ingredients": [{"name": "CLARITHROMYCIN", "strength": "500 mg/1"}], "application_number": "ANDA065489", "marketing_category": "ANDA", "marketing_start_date": "20120725", "listing_expiration_date": "20261231"}