NDC 52959-077

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Ibuprofen.

Product ID52959-077_eb1eee33-fb71-41fc-9a72-162d81554a16
NDC52959-077
Product TypeHuman Prescription Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-11-23
Marketing CategoryANDA / ANDA
Application NumberANDA078558
Labeler NameH.J. Harkins Company, Inc.
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 Through2018-12-31

Packaging

NDC 52959-077-25

25 TABLET in 1 BOTTLE (52959-077-25)
Marketing Start Date2009-11-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-077-28 [52959007728]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-24 [52959007724]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-12 [52959007712]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-90 [52959007790]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-06 [52959007706]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-25 [52959007725]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-02 [52959007702]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-16 [52959007716]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-18 [52959007718]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-15 [52959007715]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-20 [52959007720]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-21 [52959007721]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-04 [52959007704]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-14 [52959007714]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-40 [52959007740]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-70 [52959007770]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-30 [52959007730]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-60 [52959007760]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-50 [52959007750]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-00 [52959007700]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-10 [52959007710]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-45 [52959007745]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

NDC 52959-077-42 [52959007742]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA078558
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-23
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 mg/1

OpenFDA Data

SPL SET ID:366536da-fb9a-4ed1-84db-10d69d9247f2
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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