NDC 67296-0913

IBU

Ibu

IBU is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Redpharm Drug, Inc.. The primary component is Ibuprofen.

Product ID67296-0913_4db219dc-ea49-490c-e054-00144ff88e88
NDC67296-0913
Product TypeHuman Prescription Drug
Proprietary NameIBU
Generic NameIbu
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-11-20
Marketing CategoryANDA / ANDA
Application NumberANDA075682
Labeler NameRedPharm Drug, Inc.
Substance NameIBUPROFEN
Active Ingredient Strength600 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 67296-0913-1

30 TABLET in 1 BOTTLE (67296-0913-1)
Marketing Start Date2008-11-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67296-0913-1 [67296091301]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20

NDC 67296-0913-3 [67296091303]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN600 mg/1

OpenFDA Data

SPL SET ID:4db219dc-ea48-490c-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197806
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0367296091311
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "IBU" or generic name "Ibu"

    NDCBrand NameGeneric Name
    0615-8115IBUIbuprofen
    0615-8116IBUIbuprofen
    0615-8117IBUIbuprofen
    10544-071IBUIbuprofen
    10544-625IBUIbuprofen
    35356-699IBUIbuprofen
    43353-273IBUIbuprofen
    49999-042IBUIbuprofen
    50090-4331IBUIbuprofen
    50090-4333IBUIbuprofen
    50090-4339IBUIbuprofen
    50090-4341IBUIbuprofen
    50436-0684IBUIbuprofen
    50436-4604IBUIbuprofen
    50436-4605IBUIbuprofen
    51407-369IBUIbuprofen
    51407-370IBUIbuprofen
    51407-371IBUIbuprofen
    53002-3010IBUIbuprofen
    53002-3370IBUIbuprofen
    53002-3980IBUIbuprofen
    53217-366IBUIbuprofen
    55111-682IBUIbuprofen
    55111-683IBUIbuprofen
    55111-684IBUIbuprofen
    60429-219IBUIbuprofen
    60429-220IBUIbuprofen
    60429-221IBUIbuprofen
    60760-076IBUIbuprofen
    60760-135IBUIbuprofen
    61919-621IBUIBU
    68071-1827IBUIBU
    68071-3053IBUIBU
    68071-3125IBUIBU
    68071-3172IBUIBU
    70518-0490IBUIBU
    70518-1145IBUIBU
    63187-614IBUIBU
    66267-116IBUIBU
    66267-117IBUIBU
    66267-963IBUIBU
    66267-793IBUIBU
    66267-795IBUIBU
    66267-964IBUIBU
    66267-794IBUIBU
    67296-1217IBUIBU
    67296-0877IBUIBU
    67296-0913IBUIBU
    70934-195IBUIBU
    71610-275IBUIBU

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