NDC 55319-897

family wellness childrens ibuprofen

Ibuprofen

family wellness childrens ibuprofen is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Family Dollar Services Inc. The primary component is Ibuprofen.

Product ID55319-897_87655c3a-5894-4c2e-9fc6-91b15a777db1
NDC55319-897
Product TypeHuman Otc Drug
Proprietary Namefamily wellness childrens ibuprofen
Generic NameIbuprofen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2002-08-22
Marketing CategoryANDA / ANDA
Application NumberANDA074937
Labeler NameFamily Dollar Services Inc
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55319-897-12

1 BOTTLE in 1 CARTON (55319-897-12) > 120 mL in 1 BOTTLE
Marketing Start Date2019-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55319-897-28 [55319089728]

family wellness childrens ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-06-19

NDC 55319-897-26 [55319089726]

family wellness childrens ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2002-08-22

NDC 55319-897-12 [55319089712]

family wellness childrens ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-01

NDC 55319-897-76 [55319089776]

family wellness childrens ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2002-08-22
Marketing End Date2012-08-03

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN100 mg/5mL

OpenFDA Data

SPL SET ID:17bd342d-8eb3-4663-88f5-2e7c90254dc7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197803
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "family wellness childrens ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    55319-166family wellness childrens ibuprofenfamily wellness childrens ibuprofen
    55319-897family wellness childrens ibuprofenfamily wellness childrens 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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