NDC 63187-489

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Ibuprofen.

Product ID63187-489_5b5a509f-e981-4d60-ba44-f15f12cada68
NDC63187-489
Product TypeHuman Prescription Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-11-23
Marketing CategoryANDA / ANDA
Application NumberANDA078558
Labeler NameProficient Rx LP
Substance NameIBUPROFEN
Active Ingredient Strength400 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 63187-489-20

20 TABLET in 1 BOTTLE (63187-489-20)
Marketing Start Date2016-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-489-72 [63187048972]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-01

NDC 63187-489-90 [63187048990]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-01

NDC 63187-489-60 [63187048960]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-01

NDC 63187-489-20 [63187048920]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-01

NDC 63187-489-45 [63187048945]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-01

NDC 63187-489-30 [63187048930]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-01

NDC 63187-489-40 [63187048940]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-01

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN400 mg/1

OpenFDA Data

SPL SET ID:e23eb275-ce0c-40ec-b809-a48c5e46c7ec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197805
  • 197807
  • 197806
  • 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 "Ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    67877-120ibuprofenibuprofen
    67877-119ibuprofenibuprofen
    67877-295ibuprofenibuprofen
    67877-121ibuprofenibuprofen
    67877-294ibuprofenibuprofen
    67877-296ibuprofenibuprofen
    67877-321IbuprofenIbuprofen
    67877-319IbuprofenIbuprofen
    67877-320IbuprofenIbuprofen
    68016-116IbuprofenIbuprofen
    68016-633IbuprofenIbuprofen
    68016-626IbuprofenIbuprofen
    68016-634IbuprofenIbuprofen
    68016-645IbuprofenIbuprofen
    68016-295IbuprofenIbuprofen
    68016-635IbuprofenIbuprofen
    68071-3074IbuprofenIbuprofen
    68071-3362IBUPROFENIBUPROFEN
    68071-4129IbuprofenIbuprofen
    68071-4009IBUPROFENIBUPROFEN
    68071-3388IbuprofenIbuprofen
    68071-4253IbuprofenIbuprofen
    68071-4306IbuprofenIbuprofen
    68071-4357IbuprofenIbuprofen
    68071-4563IbuprofenIbuprofen
    68071-4280IbuprofenIbuprofen
    68071-4243IBUPROFENIBUPROFEN
    68071-4820IbuprofenIbuprofen
    68071-4305IbuprofenIbuprofen
    68071-4459IBUPROFENIBUPROFEN
    68084-703IbuprofenIbuprofen
    68084-658IbuprofenIbuprofen
    68084-772IbuprofenIbuprofen
    68196-980IbuprofenIbuprofen
    68196-981IbuprofenIbuprofen
    68210-0200IBUPROFENIBUPROFEN
    68196-199IbuprofenIbuprofen
    68210-0009IBUPROFENIBUPROFEN
    68196-745IbuprofenIbuprofen
    68387-208IbuprofenIbuprofen
    0472-2002IbuprofenIbuprofen
    68387-210IbuprofenIbuprofen
    68391-121IbuprofenIbuprofen
    68391-199IbuprofenIbuprofen
    0472-1270IbuprofenIbuprofen
    68645-531IbuprofenIbuprofen
    68645-563IbuprofenIbuprofen
    68645-562IbuprofenIbuprofen
    68645-561IbuprofenIbuprofen
    0113-1461basic care childrens ibuprofenIbuprofen

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