NDC 0527-1931

Clarithromycin

Clarithromycin

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

Product ID0527-1931_74263a23-9072-d8b3-e053-2a91aa0abf34
NDC0527-1931
Product TypeHuman Prescription Drug
Proprietary NameClarithromycin
Generic NameClarithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-12-04
Marketing CategoryANDA / ANDA
Application NumberANDA203584
Labeler NameLannett Company, 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 Through2019-12-31

Packaging

NDC 0527-1931-06

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1931-06)
Marketing Start Date2015-12-04
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
CLARITHROMYCIN250 mg/1

OpenFDA Data

SPL SET ID:9bf207c0-86eb-4f3b-92e7-f65f3fccd5a7
Manufacturer:Lannett Company, Inc.
UNII
RxNorm Concept Unique ID - RxCUI
  • 197517
  • 197516
  • 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
    10544-522ClarithromycinClarithromycin
    10544-952Clarithromycinclarithromycin
    21695-557ClarithromycinClarithromycin
    21695-558ClarithromycinClarithromycin
    33261-618ClarithromycinClarithromycin
    33261-631ClarithromycinClarithromycin
    42254-188ClarithromycinClarithromycin
    42291-263clarithromycinclarithromycin
    43063-520clarithromycinclarithromycin
    43063-530ClarithromycinClarithromycin
    43063-565clarithromycinclarithromycin
    43063-752ClarithromycinClarithromycin
    43063-823ClarithromycinClarithromycin
    43063-942ClarithromycinClarithromycin
    49884-238CLARITHROMYCINCLARITHROMYCIN EXTENDED-RELEASE
    49999-904ClarithromycinClarithromycin
    50090-0994ClarithromycinClarithromycin
    50090-1410clarithromycinclarithromycin
    50090-1830ClarithromycinClarithromycin
    50090-2441ClarithromycinClarithromycin
    50090-2515ClarithromycinClarithromycin
    50090-3193ClarithromycinClarithromycin
    50090-4059ClarithromycinClarithromycin
    50268-178ClarithromycinClarithromycin
    50268-179ClarithromycinClarithromycin
    51862-194ClarithromycinClarithromycin
    55648-949ClarithromycinClarithromycin
    55648-954ClarithromycinClarithromycin
    55695-018clarithromycinclarithromycin
    55700-535ClarithromycinClarithromycin
    57237-044ClarithromycinClarithromycin
    57237-045ClarithromycinClarithromycin
    59746-742ClarithromycinClarithromycin
    59746-743ClarithromycinClarithromycin
    63187-376ClarithromycinClarithromycin
    63187-625ClarithromycinClarithromycin
    63304-725ClarithromycinClarithromycin
    63304-726ClarithromycinClarithromycin
    63304-821ClarithromycinClarithromycin
    63304-822ClarithromycinClarithromycin
    63629-2887Clarithromycinclarithromycin
    63629-4448ClarithromycinClarithromycin
    63629-6763ClarithromycinClarithromycin
    63629-7832ClarithromycinClarithromycin
    64380-905CLARITHROMYCINCLARITHROMYCIN
    64380-906CLARITHROMYCINCLARITHROMYCIN
    64679-949ClarithromycinClarithromycin
    64679-954ClarithromycinClarithromycin
    65862-225ClarithromycinClarithromycin
    65862-226ClarithromycinClarithromycin
    66336-429clarithromycinclarithromycin
    67296-0464ClarithromycinClarithromycin
    67296-1072clarithromycinclarithromycin
    67296-1360ClarithromycinClarithromycin
    68071-1899ClarithromycinClarithromycin
    68071-3116ClarithromycinClarithromycin
    68071-4369ClarithromycinClarithromycin
    68084-651ClarithromycinClarithromycin
    68788-6425ClarithromycinClarithromycin
    68788-6887clarithromycinclarithromycin
    68788-6936ClarithromycinClarithromycin
    68788-6967ClarithromycinClarithromycin
    68788-7125ClarithromycinClarithromycin
    68788-9087ClarithromycinClarithromycin
    70518-0204ClarithromycinClarithromycin
    70518-1136ClarithromycinClarithromycin
    71335-0017ClarithromycinClarithromycin
    71335-0795ClarithromycinClarithromycin
    71335-0990ClarithromycinClarithromycin
    75921-962ClarithromycinClarithromycin
    76267-060ClarithromycinClarithromycin
    76267-061ClarithromycinClarithromycin
    61919-643CLARITHROMYCINCLARITHROMYCIN
    27241-064ClarithromycinClarithromycin
    27241-065ClarithromycinClarithromycin
    67296-1632ClarithromycinClarithromycin
    0904-6872ClarithromycinClarithromycin
    60687-435ClarithromycinClarithromycin
    63629-8222ClarithromycinClarithromycin
    68071-5045ClarithromycinClarithromycin
    72763-100Clarithromycin Extended-ReleaseCLARITHROMYCIN

    © 2019 FDA.report
    This site is not affiliated with or endorsed by the FDA.