NDC 0378-6281

Diclofenac Sodium

Diclofenac Sodium

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

Product ID0378-6281_5518345b-0230-4750-bf41-f14dcb7a6ff8
NDC0378-6281
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium
Generic NameDiclofenac Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2010-05-18
Marketing CategoryANDA / ANDA
Application NumberANDA075281
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength75 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-6281-10

1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6281-10)
Marketing Start Date2010-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6281-01 [00378628101]

Diclofenac Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075281
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-18
Marketing End Date2020-09-30

NDC 0378-6281-91 [00378628191]

Diclofenac Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075281
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-18
Marketing End Date2014-05-19

NDC 0378-6281-10 [00378628110]

Diclofenac Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075281
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-18
Marketing End Date2020-09-30

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

OpenFDA Data

SPL SET ID:4b0d7319-a587-4648-bded-5b35b8efa1cb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855926
  • 855906

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.