NDC 0363-0438

Dye Free Ibuprofen

Ibuprofen

Dye Free Ibuprofen is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Walgreen Company. The primary component is Ibuprofen.

Product ID0363-0438_5c9e1e18-52e3-45e5-b271-283353339315
NDC0363-0438
Product TypeHuman Otc Drug
Proprietary NameDye Free Ibuprofen
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1999-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA075139
Labeler NameWalgreen Company
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0363-0438-99

1 BOTTLE in 1 CARTON (0363-0438-99) > 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date1999-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-0438-99 [00363043899]

Dye Free Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075139
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-03-01
Marketing End Date2021-08-02

NDC 0363-0438-12 [00363043812]

Dye Free Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075139
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1999-03-01
Marketing End Date2019-04-07

NDC 0363-0438-15 [00363043815]

Dye Free Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075139
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1999-03-01
Marketing End Date2016-10-08

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:d3d093f9-207a-40d4-a7be-c6b5a544a0a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0311917088204
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Dye Free Ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    70729-002Dye Free IbuprofenDye Free Ibuprofen
    0363-0438Dye Free IbuprofenDye Free Ibuprofen
    0363-4381Dye Free IbuprofenDye Free 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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