NDC 12634-682

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 ID12634-682_36fc14a6-4944-4e90-e054-00144ff8d46c
NDC12634-682
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 Strength800 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 12634-682-85

15 TABLET in 1 BOTTLE (12634-682-85)
Marketing Start Date2008-11-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-682-82 [12634068282]

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

NDC 12634-682-94 [12634068294]

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

NDC 12634-682-81 [12634068281]

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

NDC 12634-682-79 [12634068279]

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

NDC 12634-682-99 [12634068299]

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

NDC 12634-682-01 [12634068201]

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

NDC 12634-682-60 [12634068260]

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

NDC 12634-682-91 [12634068291]

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

NDC 12634-682-71 [12634068271]

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

NDC 12634-682-95 [12634068295]

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

NDC 12634-682-74 [12634068274]

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

NDC 12634-682-61 [12634068261]

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

NDC 12634-682-78 [12634068278]

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

NDC 12634-682-42 [12634068242]

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

NDC 12634-682-96 [12634068296]

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

NDC 12634-682-67 [12634068267]

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

NDC 12634-682-69 [12634068269]

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

NDC 12634-682-40 [12634068240]

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

NDC 12634-682-57 [12634068257]

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

NDC 12634-682-66 [12634068266]

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

NDC 12634-682-59 [12634068259]

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

NDC 12634-682-63 [12634068263]

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

NDC 12634-682-54 [12634068254]

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

NDC 12634-682-80 [12634068280]

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

NDC 12634-682-00 [12634068200]

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

NDC 12634-682-50 [12634068250]

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

NDC 12634-682-85 [12634068285]

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

NDC 12634-682-09 [12634068209]

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

NDC 12634-682-52 [12634068252]

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

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 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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