NDC 50383-584

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Ibuprofen.

Product ID50383-584_3260dec9-3146-46e4-90df-c30be7fdfe4d
NDC50383-584
Product TypeHuman Prescription Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2016-11-28
Marketing CategoryANDA / ANDA
Application NumberANDA205647
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/5mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50383-584-04

1 BOTTLE in 1 CARTON (50383-584-04) > 118 mL in 1 BOTTLE
Marketing Start Date2016-11-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-584-16 [50383058416]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA205647
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-11-28

NDC 50383-584-07 [50383058407]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA205647
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-11-28

NDC 50383-584-06 [50383058406]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA205647
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-11-28

NDC 50383-584-12 [50383058412]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA205647
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-28

NDC 50383-584-04 [50383058404]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA205647
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-11-28

NDC 50383-584-10 [50383058410]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA205647
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-28

NDC 50383-584-05 [50383058405]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA205647
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-11-28

NDC 50383-584-11 [50383058411]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA205647
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-28

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN100 mg/5mL

OpenFDA Data

SPL SET ID:91573be8-238a-4942-963e-d5234311e580
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]

    Medicade Reported Pricing

    50383058416 IBUPROFEN 100 MG/5 ML SUSP

    Pricing Unit: ML | Drug Type:

    50383058404 IBUPROFEN 100 MG/5 ML SUSP

    Pricing Unit: ML | Drug Type:

    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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