NDC 68387-208

Ibuprofen

Ibuprofen

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

Product ID68387-208_a0e7b75d-817b-4584-b5cc-8eeb31fd06f2
NDC68387-208
Product TypeHuman Prescription Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-08-24
Marketing CategoryANDA / ANDA
Application NumberANDA078558
Labeler NameKeltman Pharmaceuticals 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 Through2017-12-31

Packaging

NDC 68387-208-30

30 TABLET in 1 BOTTLE, PLASTIC (68387-208-30)
Marketing Start Date2007-08-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68387-208-90 [68387020890]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-08-24
Inactivation Date2019-10-29

NDC 68387-208-30 [68387020830]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-05
Inactivation Date2019-10-29

NDC 68387-208-21 [68387020821]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-08
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN600 mg/1

OpenFDA Data

SPL SET ID:a75f4230-cd5e-4fd9-b97e-31893c10e981
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

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