NDC 45865-373

Ibuprofen

Ibuprofen

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

Product ID45865-373_b988f226-d4a8-4fa3-bea3-5f88462613b0
NDC45865-373
Product TypeHuman Prescription Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-11-23
Marketing CategoryANDA / ANDA
Application NumberANDA078558
Labeler NameMedsource Pharmaceuticals
Substance NameIBUPROFEN
Active Ingredient Strength800 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 45865-373-49

100 TABLET in 1 BOTTLE (45865-373-49)
Marketing Start Date2009-11-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-373-51 [45865037351]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-23
Inactivation Date2019-11-13

NDC 45865-373-30 [45865037330]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-23
Inactivation Date2019-11-13

NDC 45865-373-90 [45865037390]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-23
Inactivation Date2019-11-13

NDC 45865-373-60 [45865037360]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-23
Inactivation Date2019-11-13

NDC 45865-373-20 [45865037320]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-23
Inactivation Date2019-11-13

NDC 45865-373-49 [45865037349]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-23
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 mg/1

OpenFDA Data

SPL SET ID:7b0f3f87-751a-4cc3-9b9a-95bedfd7c5e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197807
  • 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

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