NDC 53041-637

Concentrated ibuprofen infants

Ibuprofen

Concentrated ibuprofen infants is a Oral Suspension/ Drops in the Human Otc Drug category. It is labeled and distributed by Guardian Drug Company. The primary component is Ibuprofen.

Product ID53041-637_3a32f0c7-c03e-4783-a429-08280993ddfb
NDC53041-637
Product TypeHuman Otc Drug
Proprietary NameConcentrated ibuprofen infants
Generic NameIbuprofen
Dosage FormSuspension/ Drops
Route of AdministrationORAL
Marketing Start Date2018-10-03
Marketing CategoryANDA / ANDA
Application NumberANDA210755
Labeler NameGuardian Drug Company
Substance NameIBUPROFEN
Active Ingredient Strength50 mg/1.25mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53041-637-09

1 BOTTLE in 1 CARTON (53041-637-09) > 30 mL in 1 BOTTLE
Marketing Start Date2018-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53041-637-09 [53041063709]

Concentrated ibuprofen infants SUSPENSION/ DROPS
Marketing CategoryANDA
Application NumberANDA210755
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-03

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN50 mg/1.25mL

OpenFDA Data

SPL SET ID:3a32f0c7-c03e-4783-a429-08280993ddfb
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 "Concentrated ibuprofen infants" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    53041-637Concentrated ibuprofen infantsConcentrated ibuprofen infants
    49035-635Concentrated ibuprofen infantsConcentrated 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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