NDC 49035-438

Ibuprofen Dye-Free

Ibuprofen

Ibuprofen Dye-Free is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Wal-mart Stores Inc. The primary component is Ibuprofen.

Product ID49035-438_00aecd6c-5a8b-4dd1-b746-6eab1cb60704
NDC49035-438
Product TypeHuman Otc Drug
Proprietary NameIbuprofen Dye-Free
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2004-03-11
Marketing CategoryANDA / ANDA
Application NumberANDA075139
Labeler NameWal-Mart Stores Inc
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 49035-438-90

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49035-438-90)
Marketing Start Date2004-03-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49035-438-12 [49035043812]

Ibuprofen Dye-Free TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075139
Product TypeHUMAN OTC DRUG
Marketing Start Date2004-03-11
Marketing End Date2021-05-16

NDC 49035-438-90 [49035043890]

Ibuprofen Dye-Free TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075139
Product TypeHUMAN OTC DRUG
Marketing Start Date2004-03-11

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:23cb5001-6aeb-434a-b2e8-aaf8bbab9dc6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0681131086738
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • NDC Crossover Matching brand name "Ibuprofen Dye-Free" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    49035-438Ibuprofen Dye-FreeIbuprofen Dye-Free
    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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