NDC 45865-983

Diclofenac Sodium Topical Solution

Diclofenac Sodium

Diclofenac Sodium Topical Solution is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Diclofenac Sodium.

Product ID45865-983_9af147ca-cb18-3194-e053-2a95a90aa0a8
NDC45865-983
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium Topical Solution
Generic NameDiclofenac Sodium
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2017-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA206715
Labeler Namemedsource pharmaceuticals
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength16 mg/mL
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 45865-983-01

1 BOTTLE, DROPPER in 1 CARTON (45865-983-01) > 150 mL in 1 BOTTLE, DROPPER
Marketing Start Date2019-12-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-983-01 [45865098301]

Diclofenac Sodium Topical Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA206715
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-11

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM16.05 mg/mL

OpenFDA Data

SPL SET ID:9af13122-73b2-95de-e053-2995a90a0505
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857700

    • 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 Topical Solution" or generic name "Diclofenac Sodium"

    NDCBrand NameGeneric Name
    68788-7151Diclofenac Sodium Topical SolutionDiclofenac Sodium Topical Solution
    50742-308Diclofenac Sodium Topical SolutionDiclofenac Sodium Topical Solution
    45865-983Diclofenac Sodium Topical SolutionDiclofenac Sodium Topical Solution
    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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