NDC 12634-191

IBUPROFEN

Ibuprofen

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

Product ID12634-191_36fc14a6-4944-4e90-e054-00144ff8d46c
NDC12634-191
Product TypeHuman Prescription Drug
Proprietary NameIBUPROFEN
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-11-20
Marketing CategoryANDA / ANDA
Application NumberANDA075682
Labeler NameApotheca Inc.
Substance NameIBUPROFEN
Active Ingredient Strength600 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 12634-191-74

24 TABLET in 1 BOTTLE (12634-191-74)
Marketing Start Date2008-11-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-191-79 [12634019179]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-95 [12634019195]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-80 [12634019180]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-42 [12634019142]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-67 [12634019167]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-54 [12634019154]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-91 [12634019191]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-96 [12634019196]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-09 [12634019109]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-78 [12634019178]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-57 [12634019157]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-94 [12634019194]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-50 [12634019150]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-82 [12634019182]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-66 [12634019166]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-40 [12634019140]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-71 [12634019171]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-90 [12634019190]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Marketing End Date2016-07-04

NDC 12634-191-01 [12634019101]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-81 [12634019181]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-85 [12634019185]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-61 [12634019161]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-59 [12634019159]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-00 [12634019100]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-60 [12634019160]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-52 [12634019152]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-63 [12634019163]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-74 [12634019174]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

NDC 12634-191-69 [12634019169]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN600 mg/1

OpenFDA Data

SPL SET ID:0396bfec-afe1-460c-8141-e8ad877b4bc0
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]

    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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