NDC 55316-647

Healthy Accents ibuprofen

Ibuprofen

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

Product ID55316-647_03a64266-8989-4540-a8a4-377c8e00fd58
NDC55316-647
Product TypeHuman Otc Drug
Proprietary NameHealthy Accents ibuprofen
Generic NameIbuprofen
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2008-05-17
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 55316-647-78

1 BOTTLE in 1 CARTON (55316-647-78) > 100 TABLET, COATED in 1 BOTTLE
Marketing Start Date2008-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-647-71 [55316064771]

Healthy Accents ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-06-22
Marketing End Date2019-06-24

NDC 55316-647-76 [55316064776]

Healthy Accents ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-10-27
Marketing End Date2010-03-07

NDC 55316-647-78 [55316064778]

Healthy Accents ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-05-17
Marketing End Date2019-06-24

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:a6e65c0d-575a-4846-bca5-274f89172e5e
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.