NDC 36800-255

Topcare Ibuprofen

Ibuprofen

Topcare Ibuprofen is a Oral Suspension/ Drops in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Ibuprofen.

Product ID36800-255_c10ff53b-f979-4be5-a5fd-2f66b893eabf
NDC36800-255
Product TypeHuman Otc Drug
Proprietary NameTopcare Ibuprofen
Generic NameIbuprofen
Dosage FormSuspension/ Drops
Route of AdministrationORAL
Marketing Start Date2004-09-10
Marketing CategoryANDA / ANDA
Application NumberANDA075217
Labeler NameTopco Associates LLC
Substance NameIBUPROFEN
Active Ingredient Strength50 mg/1.25mL
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 36800-255-10

1 BOTTLE in 1 CARTON (36800-255-10) > 30 mL in 1 BOTTLE
Marketing Start Date2004-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-255-10 [36800025510]

Topcare Ibuprofen SUSPENSION/ DROPS
Marketing CategoryANDA
Application NumberANDA075217
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2004-09-10

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN50 mg/1.25mL

OpenFDA Data

SPL SET ID:742f33fa-8923-4415-bcd6-8db37f2e1974
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204442
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • Medicade Reported Pricing

    36800025510 INFANT IBUPROFEN 50 MG/1.25 ML

    Pricing Unit: ML | Drug Type:

    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

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