NDC 36800-303

Topcare Ibuprofen

Ibuprofen

Topcare Ibuprofen is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Ibuprofen Sodium.

Product ID36800-303_d78f4d6d-04e0-438f-9909-0a5ca86ff8d6
NDC36800-303
Product TypeHuman Otc Drug
Proprietary NameTopcare Ibuprofen
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-03-23
Marketing CategoryANDA / ANDA
Application NumberANDA206581
Labeler NameTopco Associates LLC
Substance NameIBUPROFEN SODIUM
Active Ingredient Strength256 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 36800-303-60

1 BOTTLE in 1 CARTON (36800-303-60) > 20 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2016-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-303-60 [36800030360]

Topcare Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206581
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-03-23

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN SODIUM256 mg/1

OpenFDA Data

SPL SET ID:8aee01c5-b9c4-4692-ae7a-3749215da95a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
  • NDC Crossover Matching brand name "Topcare Ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    36800-074Topcare IbuprofenTopcare Ibuprofen
    36800-647Topcare IbuprofenTopcare Ibuprofen
    36800-255Topcare IbuprofenTopcare Ibuprofen
    36800-287topcare ibuprofentopcare ibuprofen
    36800-303Topcare IbuprofenTopcare Ibuprofen
    36800-604TopCare IbuprofenTopCare Ibuprofen
    36800-753topcare ibuprofentopcare ibuprofen
    36800-623topcare ibuprofentopcare ibuprofen
    36800-517Topcare ibuprofenTopcare ibuprofen
    36800-897topcare ibuprofentopcare ibuprofen
    36800-183Topcare IbuprofenTopcare 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.