NDC 55316-604

healthy accents ibuprofen

Ibuprofen

healthy accents ibuprofen is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Dza Brands Llc. The primary component is Ibuprofen.

Product ID55316-604_2cdf93d6-ee77-4490-9587-0345aa69394e
NDC55316-604
Product TypeHuman Otc Drug
Proprietary Namehealthy accents ibuprofen
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-01-22
Marketing CategoryANDA / ANDA
Application NumberANDA072096
Labeler NameDZA Brands LLC
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55316-604-71

1 BOTTLE in 1 CARTON (55316-604-71) > 50 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2008-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-604-71 [55316060471]

healthy accents ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-02-24
Marketing End Date2019-05-29

NDC 55316-604-90 [55316060490]

healthy accents ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-01-22
Marketing End Date2019-07-18

NDC 55316-604-76 [55316060476]

healthy accents ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-10-27
Marketing End Date2014-01-03

NDC 55316-604-93 [55316060493]

healthy accents ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-28
Marketing End Date2019-03-12

NDC 55316-604-62 [55316060462]

healthy accents ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-04-05
Marketing End Date2019-09-30

NDC 55316-604-78 [55316060478]

healthy accents ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-01-29
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:0cb97eef-ad02-4f9c-b872-5a15f27571b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "healthy accents ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    55316-517Healthy Accents ibuprofenHealthy Accents ibuprofen
    55316-299Healthy Accents IbuprofenHealthy Accents Ibuprofen
    55316-461Healthy Accents IbuprofenHealthy Accents Ibuprofen
    55316-897healthy accents ibuprofenhealthy accents ibuprofen
    55316-647Healthy Accents ibuprofenHealthy Accents ibuprofen
    55316-255healthy accents ibuprofenhealthy accents ibuprofen
    55316-521healthy accents ibuprofenhealthy accents ibuprofen
    55316-604healthy accents ibuprofenhealthy accents ibuprofen
    0113-1461basic care childrens ibuprofenIbuprofen
    0113-7619basic care childrens ibuprofenibuprofen
    0113-7660basic care childrens ibuprofenIbuprofen
    0113-7897Basic Care childrens ibuprofenIbuprofen
    0113-0788Basic Care ibuprofenIbuprofen
    0113-7131basic care ibuprofenIbuprofen
    0113-7517basic care ibuprofenIbuprofen
    0113-7604Basic Care IbuprofenIbuprofen
    0121-0917Childrens IbuprofenIbuprofen
    0121-0914Childrens Ibuprofen Oral SuspensionIbuprofen
    0113-2461Good Sense Childrens IbuprofenIbuprofen
    0113-0057Good Sense ibuprofenibuprofen
    0113-0074Good Sense ibuprofenIbuprofen
    0113-0166good sense ibuprofenIbuprofen
    0113-0298good sense ibuprofenIbuprofen
    0113-0461Good Sense ibuprofenIbuprofen
    0113-0517Good Sense ibuprofenIbuprofen
    0113-0604good sense ibuprofenIbuprofen
    0113-0647good sense ibuprofenIbuprofen
    0113-0660Good Sense IbuprofenIbuprofen
    0113-0685Good Sense IbuprofenIbuprofen
    0113-0897good sense ibuprofenIbuprofen
    0113-1212Good Sense IbuprofenIbuprofen
    0113-4501good sense ibuprofenibuprofen
    0113-0040Good Sense Infants IbuprofenIbuprofen

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