NDC 35418-750

Ibutab

Ibuprofen

Ibutab is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Zee Medical Inc. The primary component is Ibuprofen.

Product ID35418-750_259369b4-8c31-4579-ada7-71f44ca31961
NDC35418-750
Product TypeHuman Otc Drug
Proprietary NameIbutab
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA079129
Labeler NameZee Medical Inc
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35418-750-69

500 CARTON in 1 CARTON (35418-750-69) > 125 CARTON in 1 CARTON (35418-750-67) > 50 PACKET in 1 CARTON (35418-750-68) > 2 TABLET in 1 PACKET (35418-750-02)
Marketing Start Date2012-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35418-750-69 [35418075069]

Ibutab TABLET
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-12

NDC 35418-750-02 [35418075002]

Ibutab TABLET
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-12

NDC 35418-750-68 [35418075068]

Ibutab TABLET
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-12

NDC 35418-750-67 [35418075067]

Ibutab TABLET
Marketing CategoryANDA
Application NumberANDA079129
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-12

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:2f516c51-a1b5-4585-8de3-6271ad161608
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
  • 1359097
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0690689014216
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

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

    NDCBrand NameGeneric Name
    35418-750IbutabIbutab
    42961-050IbutabIbutab
    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

    Trademark Results [Ibutab]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    IBUTAB
    IBUTAB
    78797264 3183546 Dead/Cancelled
    Nickell, Robert P
    2006-01-23
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.