NDC 54348-830

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Ibuprofen.

Product ID54348-830_8f76c341-a373-7d4e-e053-2995a90a6aea
NDC54348-830
Product TypeHuman Prescription Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-07-11
Marketing CategoryANDA / ANDA
Application NumberANDA091625
Labeler NamePharmPak, 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 Through2020-12-31

Packaging

NDC 54348-830-00

1 BOTTLE in 1 BOX (54348-830-00) > 1 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2019-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-830-10 [54348083010]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-830-20 [54348083020]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-830-12 [54348083012]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-830-02 [54348083002]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-830-08 [54348083008]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-830-00 [54348083000]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091625
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN600 mg/1

OpenFDA Data

SPL SET ID:4d95bccd-8280-4d03-a574-927669c7cda0
Manufacturer
UNII
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]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • 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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