NDC 0168-0844

DICLOFENAC SODIUM

Diclofenac Sodium

DICLOFENAC SODIUM is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Diclofenac Sodium.

Product ID0168-0844_e0309be9-5dd6-4285-aa7a-e00e7bd4b59d
NDC0168-0844
Product TypeHuman Prescription Drug
Proprietary NameDICLOFENAC SODIUM
Generic NameDiclofenac Sodium
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2013-05-06
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021005
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength30 mg/g
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 0168-0844-01

1 TUBE in 1 CARTON (0168-0844-01) > 100 g in 1 TUBE
Marketing Start Date2016-02-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0844-01 [00168084401]

DICLOFENAC SODIUM GEL
Marketing CategoryNDA authorized generic
Application NumberNDA021005
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-02-24

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM30 mg/g

OpenFDA Data

SPL SET ID:1088cda3-a4d7-447b-9199-fb3aebc34f8f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855642

    • 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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