clarithromycin

Generic: clarithromycin

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarithromycin
Generic Name clarithromycin
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

clarithromycin 500 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-345
Product ID 46708-345_17817dba-4183-4a14-a55f-3e1240ea03a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210459
Listing Expiration 2026-12-31
Marketing Start 2022-02-01

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 46708345
Hyphenated Format 46708-345

Supplemental Identifiers

RxCUI
197516 197517
UPC
0346708344306
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 ANDA210459 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-345-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (46708-345-60)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-345-91)
source: ndc

Packages (3)

46708-345-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-345-30) 46708-345-60 60 TABLET, FILM COATED in 1 BOTTLE (46708-345-60) 46708-345-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-345-91)

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": "17817dba-4183-4a14-a55f-3e1240ea03a1", "openfda": {"nui": ["N0000175935", "M0028311", "N0000182141", "N0000190114", "N0000185503"], "upc": ["0346708344306"], "unii": ["H1250JIK0A"], "rxcui": ["197516", "197517"], "spl_set_id": ["268d21f9-02c9-41b0-9487-7968ea12720d"], "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": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-345-30)", "package_ndc": "46708-345-30", "marketing_start_date": "20220201"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (46708-345-60)", "package_ndc": "46708-345-60", "marketing_start_date": "20220201"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-345-91)", "package_ndc": "46708-345-91", "marketing_start_date": "20220201"}], "brand_name": "Clarithromycin", "product_id": "46708-345_17817dba-4183-4a14-a55f-3e1240ea03a1", "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": "46708-345", "generic_name": "Clarithromycin", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clarithromycin", "active_ingredients": [{"name": "CLARITHROMYCIN", "strength": "500 mg/1"}], "application_number": "ANDA210459", "marketing_category": "ANDA", "marketing_start_date": "20220201", "listing_expiration_date": "20261231"}