NDC 55700-445

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Tablet, Film Coated 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 ID55700-445_12d1ab29-93de-4787-9c76-165753aa8c19
NDC55700-445
Product TypeHuman Prescription Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-12-21
Marketing CategoryANDA / ANDA
Application NumberANDA091625
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameIBUPROFEN
Active Ingredient Strength600 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55700-445-00

100 TABLET, FILM COATED in 1 BOTTLE (55700-445-00)
Marketing Start Date2016-10-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-445-40 [55700044540]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-17

NDC 55700-445-30 [55700044530]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-17

NDC 55700-445-00 [55700044500]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-17

NDC 55700-445-20 [55700044520]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-17

NDC 55700-445-60 [55700044560]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-17

NDC 55700-445-90 [55700044590]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-17

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN600 mg/1

OpenFDA Data

SPL SET ID:e9a5f214-a387-4429-a875-eb1e9aa714c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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]

    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.