NDC 68071-1628

Ibuprofen Oral

Ibuprofen Oral

Ibuprofen Oral is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Ibuprofen.

Product ID68071-1628_8476495c-e2cc-a69b-e053-2a91aa0a0630
NDC68071-1628
Product TypeHuman Otc Drug
Proprietary NameIbuprofen Oral
Generic NameIbuprofen Oral
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2018-11-23
Marketing CategoryANDA / ANDA
Application NumberANDA210602
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-1628-4

118 mL in 1 BOTTLE (68071-1628-4)
Marketing Start Date2019-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-1628-4 [68071162804]

Ibuprofen Oral SUSPENSION
Marketing CategoryANDA
Application NumberANDA210602
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-03-19

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN100 mg/5mL

OpenFDA Data

SPL SET ID:84764eda-7446-5b16-e053-2991aa0abd7c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197803
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0368071162844
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Ibuprofen Oral" or generic name "Ibuprofen Oral"

    NDCBrand NameGeneric Name
    50090-4129Ibuprofen OralIbuprofen Oral
    63629-1230Ibuprofen OralIbuprofen Oral
    63629-8540Ibuprofen OralIbuprofen Oral
    63629-8851Ibuprofen OralIbuprofen Oral
    63629-8852Ibuprofen OralIbuprofen Oral
    63629-8853Ibuprofen OralIbuprofen Oral
    68071-1628Ibuprofen OralIbuprofen Oral
    68788-7984Ibuprofen OralIbuprofen Oral
    69230-308Ibuprofen OralIbuprofen Oral
    69230-309Ibuprofen OralIbuprofen Oral
    69230-310Ibuprofen OralIbuprofen Oral
    69230-311Ibuprofen OralIbuprofen Oral
    70677-0150Ibuprofen OralIbuprofen Oral
    70677-0151Ibuprofen OralIbuprofen Oral
    70677-0152Ibuprofen OralIbuprofen Oral
    70677-0153Ibuprofen OralIbuprofen Oral
    59651-032IbuprofenIbuprofen Oral

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