NDC 55319-393

Ibuprofen IB

Ibuprofen

Ibuprofen IB is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Family Dollar Services In. The primary component is Ibuprofen.

Product ID55319-393_77590135-0fe8-4905-a124-3f48a4f663df
NDC55319-393
Product TypeHuman Otc Drug
Proprietary NameIbuprofen IB
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1999-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA075139
Labeler NameFamily Dollar Services In
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55319-393-12

1 BOTTLE, PLASTIC in 1 CARTON (55319-393-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date1999-03-01
Marketing End Date2021-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55319-393-12 [55319039312]

Ibuprofen IB TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075139
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-03-01
Marketing End Date2021-11-15

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:296d0c50-5126-4e7e-8770-33db5dd6d7f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0032251005497
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • NDC Crossover Matching brand name "Ibuprofen IB" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    55319-393Ibuprofen IBIbuprofen IB
    63868-791Ibuprofen IBIbuprofen IB
    63868-794Ibuprofen IBIbuprofen IB
    63868-793Ibuprofen IBIbuprofen IB
    63868-790Ibuprofen IBIbuprofen IB
    67091-130Ibuprofen IBIbuprofen IB
    67091-129Ibuprofen IBIbuprofen IB
    67091-369Ibuprofen IBIbuprofen IB
    67091-368Ibuprofen IBIbuprofen IB
    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.