NDC 68210-0011

Assured Ibuprofen

Ibuprofen

Assured Ibuprofen is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Spirit Pharmaceuticals Llc. The primary component is Ibuprofen.

Product ID68210-0011_82f857d5-e133-ffd7-e053-2a91aa0a3f76
NDC68210-0011
Product TypeHuman Otc Drug
Proprietary NameAssured Ibuprofen
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-25
Marketing CategoryANDA / ANDA
Application NumberANDA202312
Labeler NameSpirit Pharmaceuticals LLC
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68210-0011-4

1 BOTTLE in 1 CARTON (68210-0011-4) > 40 TABLET in 1 BOTTLE
Marketing Start Date2019-02-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68210-0011-4 [68210001104]

Assured Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA202312
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-25

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:0876ecb7-6b1f-45d8-8a40-6163776d81c3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Assured Ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    68210-0011Assured IbuprofenAssured Ibuprofen
    68210-0080Assured IbuprofenAssured Ibuprofen
    68210-0081Assured IbuprofenAssured 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.