NDC 35356-725

Diclofenac Sodium

Diclofenac Sodium

Diclofenac Sodium is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Diclofenac Sodium.

Product ID35356-725_036bc7d5-c13d-438a-8699-296527d89095
NDC35356-725
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium
Generic NameDiclofenac Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2010-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA090066
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength50 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 Through2022-12-31

Packaging

NDC 35356-725-60

60 TABLET, DELAYED RELEASE in 1 BOTTLE (35356-725-60)
Marketing Start Date2013-02-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-725-60 [35356072560]

Diclofenac Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-02-07

NDC 35356-725-90 [35356072590]

Diclofenac Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-02-07
Marketing End Date2019-10-11

NDC 35356-725-30 [35356072530]

Diclofenac Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-02-07
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM50 mg/1

OpenFDA Data

SPL SET ID:bfa8cb40-3528-4d41-ae77-444e521e30c0
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
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