NDC 55316-057

healthy accents ibuprofen infants

Ibuprofen

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

Product ID55316-057_5015bfe3-edf0-4ac2-b0c8-33ca20dace69
NDC55316-057
Product TypeHuman Otc Drug
Proprietary Namehealthy accents ibuprofen infants
Generic NameIbuprofen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2008-02-18
Marketing CategoryANDA / ANDA
Application NumberANDA075217
Labeler NameDZA Brands LLC
Substance NameIBUPROFEN
Active Ingredient Strength50 mg/1.25mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55316-057-05

1 BOTTLE in 1 CARTON (55316-057-05) > 15 mL in 1 BOTTLE
Marketing Start Date2008-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-057-05 [55316005705]

healthy accents ibuprofen infants SUSPENSION
Marketing CategoryANDA
Application NumberANDA075217
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-02-18
Marketing End Date2019-08-13

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN50 mg/1.25mL

OpenFDA Data

SPL SET ID:4023fb65-10c0-4602-bd3c-f8f6c86fc93a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204442
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "healthy accents ibuprofen infants" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    55316-057healthy accents ibuprofen infantshealthy accents ibuprofen infants
    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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