NDC 0378-0471

Fenoprofen Calcium

Fenoprofen Calcium

Fenoprofen Calcium 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 Fenoprofen Calcium.

Product ID0378-0471_fd73167d-735d-42de-8d16-20571f905c39
NDC0378-0471
Product TypeHuman Prescription Drug
Proprietary NameFenoprofen Calcium
Generic NameFenoprofen Calcium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-11-14
Marketing End Date2020-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA072267
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFENOPROFEN CALCIUM
Active Ingredient Strength600 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-0471-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0471-01)
Marketing Start Date2012-11-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0471-01 [00378047101]

Fenoprofen Calcium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA072267
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-14
Marketing End Date2020-08-31

Drug Details

Active Ingredients

IngredientStrength
FENOPROFEN CALCIUM600 mg/1

OpenFDA Data

SPL SET ID:f90becaa-a4f3-44aa-ac8c-c69935c5ddb2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310291
  • 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 "Fenoprofen Calcium" or generic name "Fenoprofen Calcium"

    NDCBrand NameGeneric Name
    0276-0501Fenoprofen CalciumFenoprofen Calcium
    0276-0502Fenoprofen CalciumFenoprofen Calcium
    0276-0503Fenoprofen CalciumFenoprofen Calcium
    0378-0471Fenoprofen CalciumFenoprofen Calcium
    15014-400Fenoprofen CalciumFenoprofen Calcium
    16571-688FENOPROFEN CALCIUMFENOPROFEN CALCIUM
    42195-100Fenoprofen Calciumfenoprofen calcium
    42195-471Fenoprofen CalciumFenoprofen Calcium
    50090-3572Fenoprofen Calciumfenoprofen calcium
    53217-169Fenoprofen Calciumfenoprofen calcium
    54288-131FENOPROFEN CALCIUMFENOPROFEN CALCIUM
    54288-132FENOPROFEN CALCIUMFENOPROFEN CALCIUM
    55289-334Fenoprofen CalciumFenoprofen Calcium
    63629-8016Fenoprofen Calciumfenoprofen calcium
    69101-400Fenoprofen CalciumFenoprofen Calcium
    69336-124FENOPROFEN CALCIUMFENOPROFEN CALCIUM
    71335-0307Fenoprofen CalciumFenoprofen Calcium
    62250-691FENOPROFENFENOPROFEN CALCIUM
    42195-308Nalfonfenoprofen calcium
    42195-600Nalfonfenoprofen calcium
    42195-688NALFONFenoprofen Calcium
    55700-853Nalfonfenoprofen calcium
    63187-706Nalfonfenoprofen calcium
    63629-7515Nalfonfenoprofen calcium

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