NDC 0591-2805

clarithromycin

Clarithromycin

clarithromycin is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Clarithromycin.

Product ID0591-2805_0f500bad-5401-4f34-aebe-42c1ec4ea45c
NDC0591-2805
Product TypeHuman Prescription Drug
Proprietary Nameclarithromycin
Generic NameClarithromycin
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-02-27
Marketing CategoryANDA / ANDA
Application NumberANDA065145
Labeler NameActavis Pharma, Inc.
Substance NameCLARITHROMYCIN
Active Ingredient Strength500 mg/1
Pharm ClassesCytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0591-2805-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2805-60)
Marketing Start Date2014-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-2805-60 [00591280560]

clarithromycin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA065145
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-02-27

NDC 0591-2805-05 [00591280505]

clarithromycin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA065145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-27
Marketing End Date2014-02-27

NDC 0591-2805-10 [00591280510]

clarithromycin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA065145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-27
Marketing End Date2014-02-27

Drug Details

Active Ingredients

IngredientStrength
CLARITHROMYCIN500 mg/1

OpenFDA Data

SPL SET ID:d5be5f12-6392-4d7d-ab23-ebc205ac1a85
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359385

    • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]

    NDC Crossover Matching brand name "clarithromycin" or generic name "Clarithromycin"

    NDCBrand NameGeneric Name
    0054-0036Clarithromycinclarithromycin
    0054-0037Clarithromycinclarithromycin
    0093-7528ClarithromycinClarithromycin
    0093-7529ClarithromycinClarithromycin
    0527-1930ClarithromycinClarithromycin
    0527-1931ClarithromycinClarithromycin
    0527-1932ClarithromycinClarithromycin
    0591-2805clarithromycinclarithromycin
    0781-1961ClarithromycinClarithromycin
    0781-1962ClarithromycinClarithromycin
    0781-6022ClarithromycinClarithromycin
    0781-6023ClarithromycinClarithromycin
    0904-6872ClarithromycinClarithromycin
    10544-522ClarithromycinClarithromycin
    10544-952Clarithromycinclarithromycin
    21695-557ClarithromycinClarithromycin
    21695-558ClarithromycinClarithromycin
    27241-064ClarithromycinClarithromycin
    27241-065ClarithromycinClarithromycin
    33261-618ClarithromycinClarithromycin
    33261-631ClarithromycinClarithromycin
    68071-1899ClarithromycinClarithromycin
    68071-3116ClarithromycinClarithromycin
    68084-651ClarithromycinClarithromycin
    68788-6425ClarithromycinClarithromycin
    68788-6967ClarithromycinClarithromycin
    68788-6887clarithromycinclarithromycin
    68788-6936ClarithromycinClarithromycin
    68788-7125ClarithromycinClarithromycin
    68788-9087ClarithromycinClarithromycin
    70518-0204ClarithromycinClarithromycin
    70518-1136ClarithromycinClarithromycin
    71335-0017ClarithromycinClarithromycin
    71335-0795ClarithromycinClarithromycin
    75921-962ClarithromycinClarithromycin
    76267-061ClarithromycinClarithromycin
    76267-060ClarithromycinClarithromycin
    42254-188ClarithromycinClarithromycin
    42291-263clarithromycinclarithromycin
    43063-530ClarithromycinClarithromycin
    43063-565clarithromycinclarithromycin
    43063-752ClarithromycinClarithromycin
    43063-520clarithromycinclarithromycin
    43063-823ClarithromycinClarithromycin
    43063-942ClarithromycinClarithromycin
    49884-238CLARITHROMYCINCLARITHROMYCIN
    49999-904ClarithromycinClarithromycin
    50090-0994ClarithromycinClarithromycin
    50090-1410clarithromycinclarithromycin
    50090-2515ClarithromycinClarithromycin
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