NDC 50580-100

Infants Motrin

Ibuprofen

Infants Motrin is a Oral Suspension/ Drops in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Ibuprofen.

Product ID50580-100_6c404eb4-3916-4763-972b-081705545efb
NDC50580-100
Product TypeHuman Otc Drug
Proprietary NameInfants Motrin
Generic NameIbuprofen
Dosage FormSuspension/ Drops
Route of AdministrationORAL
Marketing Start Date2004-06-01
Marketing CategoryNDA / NDA
Application NumberNDA020603
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameIBUPROFEN
Active Ingredient Strength50 mg/1.25mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-100-18

1 BOTTLE in 1 CARTON (50580-100-18) > 15 mL in 1 BOTTLE
Marketing Start Date2012-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-100-18 [50580010018]

Infants Motrin SUSPENSION/ DROPS
Marketing CategoryNDA
Application NumberNDA020603
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-05-15

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN50 mg/1.25mL

OpenFDA Data

SPL SET ID:c2302bfe-b367-4867-b803-29f066a42dc7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854762
  • 204442
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Infants Motrin" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    50580-100Infants MotrinInfants Motrin
    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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