NDC 0093-7528

Clarithromycin

Clarithromycin

Clarithromycin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Clarithromycin.

Product ID0093-7528_1dac6b99-de32-424c-b9fe-6aa1abd59e10
NDC0093-7528
Product TypeHuman Prescription Drug
Proprietary NameClarithromycin
Generic NameClarithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-12-16
Marketing CategoryANDA / ANDA
Application NumberANDA065155
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameCLARITHROMYCIN
Active Ingredient Strength250 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 Through2020-12-31

Packaging

NDC 0093-7528-06

60 TABLET, FILM COATED in 1 BOTTLE (0093-7528-06)
Marketing Start Date2014-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-7528-06 [00093752806]

Clarithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065155
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-12-16

Drug Details

Active Ingredients

IngredientStrength
CLARITHROMYCIN250 mg/1

OpenFDA Data

SPL SET ID:9ba11bf3-5149-4f5f-9bfd-2b79ebb8f4a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197517
  • 197516
  • UPC Code
  • 0300937528067
  • 0300937529064
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.