NDC 68210-0080

Assured Ibuprofen

Ibuprofen

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

Product ID68210-0080_798669c8-26aa-13d5-e053-2a91aa0acd9c
NDC68210-0080
Product TypeHuman Otc Drug
Proprietary NameAssured Ibuprofen
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-11-22
Marketing CategoryANDA / ANDA
Application NumberANDA091239
Labeler NameSpirit Pharmaceutical LLC
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68210-0080-3

1 BOTTLE in 1 CARTON (68210-0080-3) > 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2018-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68210-0080-6 [68210008006]

Assured Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091239
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-22

NDC 68210-0080-3 [68210008003]

Assured Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091239
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-31

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:a4e5c36e-0742-4b4a-abed-baace5873645
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
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