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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

clarithromycin 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-942
Product ID 43063-942_415eafd4-5d9c-7a6d-e063-6294a90a0f28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208987
Listing Expiration 2026-12-31
Marketing Start 2019-09-10

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 43063942
Hyphenated Format 43063-942

Supplemental Identifiers

RxCUI
359385
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 ANDA208987 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-942-14)
source: ndc

Packages (1)

43063-942-14 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-942-14)

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": "415eafd4-5d9c-7a6d-e063-6294a90a0f28", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "unii": ["H1250JIK0A"], "rxcui": ["359385"], "spl_set_id": ["1d328f5d-73c1-4df7-a3df-71d0e0221181"], "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": "14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-942-14)", "package_ndc": "43063-942-14", "marketing_start_date": "20190910"}], "brand_name": "Clarithromycin", "product_id": "43063-942_415eafd4-5d9c-7a6d-e063-6294a90a0f28", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Macrolide Antimicrobial [EPC]", "Macrolides [CS]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "43063-942", "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": "ANDA208987", "marketing_category": "ANDA", "marketing_start_date": "20190910", "listing_expiration_date": "20261231"}