NDC 10337-803

Solaraze

Diclofenac Sodium

Solaraze is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Pharmaderm A Division Of Fougera Pharmaceuticals Inc.. The primary component is Diclofenac Sodium.

Product ID10337-803_1b521631-02df-447f-bfcc-1556606b652e
NDC10337-803
Product TypeHuman Prescription Drug
Proprietary NameSolaraze
Generic NameDiclofenac Sodium
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2000-10-16
Marketing CategoryNDA / NDA
Application NumberNDA021005
Labeler NamePharmaDerm 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 10337-803-01

1 TUBE in 1 CARTON (10337-803-01) > 100 g in 1 TUBE
Marketing Start Date2000-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10337-803-97 [10337080397]

Solaraze GEL
Marketing CategoryNDA
Application NumberNDA021005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-10-16

NDC 10337-803-81 [10337080381]

Solaraze GEL
Marketing CategoryNDA
Application NumberNDA021005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-10-16

NDC 10337-803-08 [10337080308]

Solaraze GEL
Marketing CategoryNDA
Application NumberNDA021005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-10-16

NDC 10337-803-01 [10337080301]

Solaraze GEL
Marketing CategoryNDA
Application NumberNDA021005
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2000-10-16

NDC 10337-803-99 [10337080399]

Solaraze GEL
Marketing CategoryNDA
Application NumberNDA021005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-10-16

NDC 10337-803-05 [10337080305]

Solaraze GEL
Marketing CategoryNDA
Application NumberNDA021005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-10-16
Marketing End Date2011-12-22

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM30 mg/g

OpenFDA Data

SPL SET ID:89a7bfbd-051f-4d87-a642-96b0df81b8e2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855642
  • 855644

    • 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]

    Medicade Reported Pricing

    10337080301 SOLARAZE 3% GEL

    Pricing Unit: GM | Drug Type:

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

    NDCBrand NameGeneric Name
    10337-803SolarazeSolaraze
    10337-844SolarazeSolaraze
    0280-0039Aleve Arthritis Pain GelDiclofenac Sodium
    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
    0113-1189good sense arthritis paindiclofenac sodium
    0067-8152Voltarendiclofenac sodium
    0067-8153Voltarendiclofenac sodium
    0078-0478VOLTARENdiclofenac sodium

    Trademark Results [Solaraze]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SOLARAZE
    SOLARAZE
    76122015 2843401 Live/Registered
    FOUGERA PHARMACEUTICALS INC.
    2000-09-05
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