NDC 12634-171

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 ID12634-171_36fc14a6-4944-4e90-e054-00144ff8d46c
NDC12634-171
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 Strength400 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 12634-171-95

5 TABLET in 1 BOTTLE (12634-171-95)
Marketing Start Date2008-11-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-171-42 [12634017142]

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

NDC 12634-171-69 [12634017169]

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

NDC 12634-171-61 [12634017161]

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

NDC 12634-171-82 [12634017182]

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

NDC 12634-171-74 [12634017174]

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

NDC 12634-171-91 [12634017191]

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

NDC 12634-171-85 [12634017185]

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

NDC 12634-171-80 [12634017180]

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

NDC 12634-171-01 [12634017101]

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

NDC 12634-171-71 [12634017171]

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

NDC 12634-171-78 [12634017178]

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

NDC 12634-171-50 [12634017150]

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

NDC 12634-171-94 [12634017194]

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

NDC 12634-171-60 [12634017160]

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

NDC 12634-171-95 [12634017195]

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

NDC 12634-171-52 [12634017152]

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

NDC 12634-171-40 [12634017140]

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

NDC 12634-171-09 [12634017109]

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

NDC 12634-171-79 [12634017179]

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

NDC 12634-171-54 [12634017154]

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

NDC 12634-171-57 [12634017157]

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

NDC 12634-171-63 [12634017163]

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

NDC 12634-171-00 [12634017100]

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

NDC 12634-171-96 [12634017196]

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

NDC 12634-171-59 [12634017159]

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

NDC 12634-171-66 [12634017166]

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

NDC 12634-171-81 [12634017181]

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

NDC 12634-171-67 [12634017167]

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

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN400 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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