NDC 0378-0093

Flurbiprofen

Flurbiprofen

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

Product ID0378-0093_81970638-c9fa-4010-9908-3cca07fd92e5
NDC0378-0093
Product TypeHuman Prescription Drug
Proprietary NameFlurbiprofen
Generic NameFlurbiprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1994-06-20
Marketing CategoryANDA / ANDA
Application NumberANDA074358
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFLURBIPROFEN
Active Ingredient Strength100 mg/1
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 0378-0093-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0093-01)
Marketing Start Date1994-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0093-01 [00378009301]

Flurbiprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074358
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-06-20
Marketing End Date2020-08-31

NDC 0378-0093-05 [00378009305]

Flurbiprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074358
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-06-20
Marketing End Date2014-01-27

Drug Details

Active Ingredients

IngredientStrength
FLURBIPROFEN100 mg/1

OpenFDA Data

SPL SET ID:86b915c9-9c00-46c2-8dd9-3e15a6b42323
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197724
  • 197725
  • 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]

    NDC Crossover Matching brand name "Flurbiprofen" or generic name "Flurbiprofen"

    NDCBrand NameGeneric Name
    0093-0711FlurbiprofenFlurbiprofen
    0378-0076Flurbiprofenflurbiprofen
    0378-0093Flurbiprofenflurbiprofen
    43063-992FlurbiprofenFlurbiprofen
    45865-918FlurbiprofenFlurbiprofen
    49999-311FlurbiprofenFlurbiprofen
    50090-0509FlurbiprofenFlurbiprofen
    55289-561Flurbiprofenflurbiprofen
    63629-8338FlurbiprofenFlurbiprofen
    63629-8808FlurbiprofenFlurbiprofen
    68071-2480FlurbiprofenFlurbiprofen
    68071-4436FlurbiprofenFlurbiprofen
    68788-7341FlurbiprofenFlurbiprofen
    69642-1300Antiphlamine Pain RelievingFlurbiprofen

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