NDC 55316-461

Healthy Accents Ibuprofen

Ibuprofen

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

Product ID55316-461_52b04a12-fccd-41e4-83dc-e6ee460146e0
NDC55316-461
Product TypeHuman Otc Drug
Proprietary NameHealthy Accents Ibuprofen
Generic NameIbuprofen
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2011-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA076359
Labeler NameDZA Brands LLC
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55316-461-62

1 BOTTLE in 1 CARTON (55316-461-62) > 24 TABLET, CHEWABLE in 1 BOTTLE
Marketing Start Date2011-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-461-62 [55316046162]

Healthy Accents Ibuprofen TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA076359
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-06-30
Marketing End Date2019-05-25

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN100 mg/1

OpenFDA Data

SPL SET ID:0437821b-79e6-4bdc-950b-898f1ce5b0d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310963
  • 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

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