NDC 68094-600

Dye Free Childrens Ibuprofen

Ibuprofen

Dye Free Childrens Ibuprofen is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Precision Dose Inc.. The primary component is Ibuprofen.

Product ID68094-600_20ac0a1c-81ab-4b54-80a0-abd0f5243ed6
NDC68094-600
Product TypeHuman Otc Drug
Proprietary NameDye Free Childrens Ibuprofen
Generic NameIbuprofen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2015-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA074937
Labeler NamePrecision Dose Inc.
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/5mL
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68094-600-61

10 TRAY in 1 CASE (68094-600-61) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-600-59)
Marketing Start Date2015-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68094-600-61 [68094060061]

Dye Free Childrens Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-08-26

NDC 68094-600-62 [68094060062]

Dye Free Childrens Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-08-26

NDC 68094-600-59 [68094060059]

Dye Free Childrens Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-08-26

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN100 mg/5mL

OpenFDA Data

SPL SET ID:eccee4c6-aa94-468a-aebd-265d7a9efb6d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197803
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Dye Free Childrens Ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    68094-600Dye Free Childrens IbuprofenDye Free Childrens 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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