NDC 37012-255

Infants Ibuprofen

Ibuprofen

Infants Ibuprofen is a Oral Suspension/ Drops in the Human Otc Drug category. It is labeled and distributed by Shopko Stores Operating Co., Llc. The primary component is Ibuprofen.

Product ID37012-255_ae96cb5d-93f1-4e73-9788-610d19d2f137
NDC37012-255
Product TypeHuman Otc Drug
Proprietary NameInfants Ibuprofen
Generic NameIbuprofen
Dosage FormSuspension/ Drops
Route of AdministrationORAL
Marketing Start Date2013-07-30
Marketing CategoryANDA / ANDA
Application NumberANDA075217
Labeler NameShopko Stores Operating Co., LLC
Substance NameIBUPROFEN
Active Ingredient Strength50 mg/1.25mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 37012-255-10

1 BOTTLE in 1 CARTON (37012-255-10) > 30 mL in 1 BOTTLE
Marketing Start Date2013-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 37012-255-10 [37012025510]

Infants Ibuprofen SUSPENSION/ DROPS
Marketing CategoryANDA
Application NumberANDA075217
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-07-30

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN50 mg/1.25mL

OpenFDA Data

SPL SET ID:d1bf3a9f-1e67-4ebe-8730-8d0e390de91b
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 "Infants Ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    68016-125Infants IbuprofenInfants Ibuprofen
    71205-110Infants IbuprofenInfants Ibuprofen
    11822-1250Infants IbuprofenInfants Ibuprofen
    37808-255infants ibuprofeninfants ibuprofen
    37012-255Infants IbuprofenInfants Ibuprofen
    45963-125Infants IbuprofenInfants Ibuprofen
    49035-125Infants IbuprofenInfants Ibuprofen
    55319-250Infants IbuprofenInfants Ibuprofen
    59779-925Infants IbuprofenInfants Ibuprofen
    59779-995infants ibuprofeninfants ibuprofen
    0363-1252Infants IbuprofenInfants Ibuprofen
    63941-125Infants IbuprofenInfants Ibuprofen
    63868-076Infants IbuprofenInfants Ibuprofen
    0363-5100Infants IbuprofenInfants 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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