NDC 0121-4774

IBUPROFEN

Ibuprofen

IBUPROFEN is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Ibuprofen.

Product ID0121-4774_61fabc0c-4e17-793e-e053-2a91aa0a4f4b
NDC0121-4774
Product TypeHuman Prescription Drug
Proprietary NameIBUPROFEN
Generic NameIbuprofen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2004-09-23
Marketing CategoryANDA / ANDA
Application NumberANDA076925
Labeler NamePharmaceutical Associates, Inc.
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/5mL
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 0121-4774-10

4 TRAY in 1 CASE (0121-4774-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2017-12-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4774-40 [00121477440]

IBUPROFEN SUSPENSION
Marketing CategoryANDA
Application NumberANDA076925
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-11

NDC 0121-4774-05 [00121477405]

IBUPROFEN SUSPENSION
Marketing CategoryANDA
Application NumberANDA076925
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-09-23

NDC 0121-4774-10 [00121477410]

IBUPROFEN SUSPENSION
Marketing CategoryANDA
Application NumberANDA076925
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-11

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN100 mg/5mL

OpenFDA Data

SPL SET ID:95f98c31-72db-4324-9059-e601d24d0302
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197803
    • 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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