NDC 69336-827

DICLOZOR

Diclofenac Sodium

DICLOZOR is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Sterling-knight Pharmaceuticals, Llc. The primary component is Diclofenac Sodium.

Product ID69336-827_8bc0f638-1e2d-4d3e-869e-eb36ce34b581
NDC69336-827
Product TypeHuman Prescription Drug
Proprietary NameDICLOZOR
Generic NameDiclofenac Sodium
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2016-10-04
Marketing CategoryANDA / ANDA
Application NumberANDA208077
Labeler NameSterling-Knight Pharmaceuticals, LLC
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength1 g/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69336-827-01

1 TUBE in 1 CARTON (69336-827-01) > 1 GEL in 1 TUBE
Marketing Start Date2016-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69336-827-01 [69336082701]

DICLOZOR GEL
Marketing CategoryANDA
Application NumberANDA208077
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-04
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM1 g/1

OpenFDA Data

SPL SET ID:3a8ba2a1-95c2-4a1f-bf1b-b92a212ff6a4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855633

    • 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 "DICLOZOR" or generic name "Diclofenac Sodium"

    NDCBrand NameGeneric Name
    69336-827DICLOZORDICLOZOR
    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
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