NDC 49999-042

IBU

Ibuprofen

IBU is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Ibuprofen.

Product ID49999-042_0e164868-3781-4b14-9688-59db607420c7
NDC49999-042
Product TypeHuman Prescription Drug
Proprietary NameIBU
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-10-19
Marketing CategoryANDA / ANDA
Application NumberANDA076112
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameIBUPROFEN
Active Ingredient Strength800 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49999-042-20

20 TABLET in 1 BOTTLE, PLASTIC (49999-042-20)
Marketing Start Date2010-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49999-042-00 [49999004200]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Marketing End Date2014-06-01

NDC 49999-042-21 [49999004221]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-09

NDC 49999-042-15 [49999004215]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Marketing End Date2014-06-01

NDC 49999-042-25 [49999004225]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Marketing End Date2014-06-01

NDC 49999-042-90 [49999004290]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19

NDC 49999-042-10 [49999004210]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Marketing End Date2014-06-01

NDC 49999-042-50 [49999004250]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Marketing End Date2014-06-01

NDC 49999-042-20 [49999004220]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19

NDC 49999-042-18 [49999004218]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Marketing End Date2014-06-01

NDC 49999-042-60 [49999004260]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Marketing End Date2014-06-01

NDC 49999-042-01 [49999004201]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Marketing End Date2014-06-01

NDC 49999-042-40 [49999004240]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19

NDC 49999-042-30 [49999004230]

IBU TABLET
Marketing CategoryANDA
Application NumberANDA076112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 mg/1

OpenFDA Data

SPL SET ID:a156e748-72c2-437a-a778-1e665157baba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197807
  • 206917
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

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

    NDCBrand NameGeneric Name
    68071-1827IBUIBU
    68071-3053IBUIBU
    68071-3125IBUIBU
    68071-3172IBUIBU
    70518-0490IBUIBU
    70518-1145IBUIBU
    10544-071IBUIBU
    10544-625IBUIBU
    35356-699IBUIBU
    43353-273IBUIBU
    49999-042IBUIBU
    50436-0684IBUIBU
    50436-4605IBUIBU
    50436-4604IBUIBU
    53002-3370IBUIBU
    53002-3980IBUIBU
    53002-3010IBUIBU
    53217-366IBUIBU
    55111-683IBUIBU
    55111-684IBUIBU
    55111-682IBUIBU
    60429-219IBUIBU
    60429-220IBUIBU
    60429-221IBUIBU
    60760-135IBUIBU
    60760-076IBUIBU
    61919-621IBUIBU
    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
    0615-8116IBUIBU
    0615-8115IBUIBU
    0615-8117IBUIBU
    50090-4341IBUIBU
    50090-4333IBUIBU
    0113-1461basic care childrens ibuprofenIbuprofen
    0113-7619basic care childrens ibuprofenibuprofen
    0113-7660basic care childrens ibuprofenIbuprofen
    0113-7897Basic Care childrens ibuprofenIbuprofen
    0113-0788Basic Care ibuprofenIbuprofen
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