NDC 49999-904

Clarithromycin

Clarithromycin

Clarithromycin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Clarithromycin.

Product ID49999-904_69bb95fd-e7cb-4458-9307-efceaacdbe9c
NDC49999-904
Product TypeHuman Prescription Drug
Proprietary NameClarithromycin
Generic NameClarithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA065136
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameCLARITHROMYCIN
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 49999-904-14

14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49999-904-14)
Marketing Start Date2010-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49999-904-30 [49999090430]

Clarithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065136
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15

NDC 49999-904-20 [49999090420]

Clarithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065136
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15

NDC 49999-904-14 [49999090414]

Clarithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065136
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-15

Drug Details

Active Ingredients

IngredientStrength
CLARITHROMYCIN500 mg/1

OpenFDA Data

SPL SET ID:c28c5e33-5de2-4e92-a75a-4afc7a873554
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197517

    • Pharmacological Class

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