NDC 63187-475

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 Proficient Rx Lp. The primary component is Diclofenac Sodium.

Product ID63187-475_4f56a848-664c-45f9-beb0-3f24fb3022fc
NDC63187-475
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium
Generic NameDiclofenac Sodium
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2002-11-06
Marketing CategoryANDA / ANDA
Application NumberANDA076201
Labeler NameProficient Rx LP
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength100 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 Through2020-12-31

Packaging

NDC 63187-475-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-475-30)
Marketing Start Date2015-02-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-475-60 [63187047560]

Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076201
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-02

NDC 63187-475-90 [63187047590]

Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076201
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-02-02

NDC 63187-475-15 [63187047515]

Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076201
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-02-02

NDC 63187-475-20 [63187047520]

Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076201
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-01

NDC 63187-475-30 [63187047530]

Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076201
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-02

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM100 mg/1

OpenFDA Data

SPL SET ID:8e0913b3-2b0c-41b6-bbfe-10aa3262e1dc
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]
    • 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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