NDC 68788-6388

Diclofenac Sodium

Diclofenac Sodium

Diclofenac Sodium is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Diclofenac Sodium.

Product ID68788-6388_490b4c79-a3e2-4587-a0c0-8f78d524c90a
NDC68788-6388
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium
Generic NameDiclofenac Sodium
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-05-05
Marketing CategoryANDA / ANDA
Application NumberANDA075492
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength100 mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68788-6388-1

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-6388-1)
Marketing Start Date2016-05-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-6388-6 [68788638806]

Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075492
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-05

NDC 68788-6388-1 [68788638801]

Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075492
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-05

NDC 68788-6388-3 [68788638803]

Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075492
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-05

NDC 68788-6388-8 [68788638808]

Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075492
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-05

NDC 68788-6388-9 [68788638809]

Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075492
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-05

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM100 mg/1

OpenFDA Data

SPL SET ID:2c8353bd-aa91-4cc3-827f-15230ab6295c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855657

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Decreased Prostaglandin Production [PE]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "Diclofenac Sodium" or generic name "Diclofenac Sodium"

    NDCBrand NameGeneric Name
    0115-1483Diclofenac SodiumDiclofenac Sodium
    0168-0803DICLOFENAC SODIUMdiclofenac sodium
    0168-0844DICLOFENAC SODIUMdiclofenac sodium
    0228-2550Diclofenac SodiumDiclofenac Sodium
    0228-2551Diclofenac SodiumDiclofenac Sodium
    0363-1210Diclofenac sodiumDiclofenac sodium
    0363-1871diclofenac sodiumdiclofenac sodium
    0378-0355Diclofenac SodiumDiclofenac Sodium
    0378-6280Diclofenac Sodiumdiclofenac sodium
    0378-6281Diclofenac Sodiumdiclofenac sodium
    67544-899Diclofenac SodiumDiclofenac Sodium
    68001-200Diclofenac SodiumDiclofenac Sodium
    68001-201Diclofenac SodiumDiclofenac Sodium
    68001-202Diclofenac SodiumDiclofenac Sodium
    68001-279Diclofenac SodiumDiclofenac Sodium
    68001-280Diclofenac SodiumDiclofenac Sodium
    68001-281Diclofenac SodiumDiclofenac Sodium
    68071-2045Diclofenac SodiumDiclofenac Sodium
    68071-3159Diclofenac sodiumDiclofenac sodium
    68071-3325Diclofenac SodiumDiclofenac Sodium
    68071-3132Diclofenac SodiumDiclofenac Sodium
    68071-4158Diclofenac SodiumDiclofenac Sodium
    68071-4382Diclofenac SodiumDiclofenac Sodium
    68071-4246Diclofenac sodiumDiclofenac sodium
    68084-333Diclofenac SodiumDiclofenac Sodium
    68151-0849Diclofenac SodiumDiclofenac Sodium
    68151-2481Diclofenac SodiumDiclofenac Sodium
    68180-538Diclofenac SodiumDiclofenac Sodium
    0472-1783Diclofenac SodiumDiclofenac Sodium
    68387-260Diclofenac SodiumDiclofenac Sodium
    68382-999Diclofenac sodiumDiclofenac sodium
    68462-355DICLOFENAC SODIUMDICLOFENAC SODIUM
    68682-103Diclofenac SodiumDiclofenac Sodium
    68788-7270Diclofenac SodiumDiclofenac Sodium
    68788-6368Diclofenac SodiumDiclofenac Sodium
    68788-6388Diclofenac SodiumDiclofenac Sodium
    68788-6831Diclofenac sodiumDiclofenac sodium
    68788-7225Diclofenac sodiumDiclofenac sodium
    68788-7097Diclofenac SodiumDiclofenac Sodium
    68788-6952Diclofenac SodiumDiclofenac Sodium
    68788-9231Diclofenac SodiumDiclofenac Sodium
    68788-9389Diclofenac SodiumDiclofenac Sodium
    68788-9523Diclofenac SodiumDiclofenac Sodium
    68788-9175Diclofenac SodiumDiclofenac Sodium
    68788-9185Diclofenac SodiumDiclofenac Sodium
    68788-9435DICLOFENAC SODIUMDICLOFENAC SODIUM
    69097-524Diclofenac SodiumDiclofenac Sodium
    0527-2170Diclofenac SodiumDiclofenac Sodium
    69621-300Diclofenac SodiumDiclofenac Sodium
    69837-399DICLOFENAC SODIUMDICLOFENAC SODIUM
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