NDC 68071-3116

Clarithromycin

Clarithromycin

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

Product ID68071-3116_84a1b30e-6be8-304c-e053-2a91aa0afa84
NDC68071-3116
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 NameNuCare Pharmaceuticals, Inc.
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 Through2020-12-31

Packaging

NDC 68071-3116-2

20 TABLET, FILM COATED in 1 BOTTLE (68071-3116-2)
Marketing Start Date2017-03-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-3116-2 [68071311602]

Clarithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-08

NDC 68071-3116-4 [68071311604]

Clarithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-08

NDC 68071-3116-8 [68071311608]

Clarithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-08

NDC 68071-3116-3 [68071311603]

Clarithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-08

Drug Details

Active Ingredients

IngredientStrength
CLARITHROMYCIN500 mg/1

OpenFDA Data

SPL SET ID:4a3febd5-8cf4-5306-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197517
    • UPC Code
  • 0368071311624

    • 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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