NDC 51655-308

DICLOFENAC SODIUM DR

Diclofenac Sodium

DICLOFENAC SODIUM DR is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Northwind Pharmaceuticals. The primary component is Diclofenac Sodium.

Product ID51655-308_0cda0108-e1b3-4d69-8894-ee9599b359d6
NDC51655-308
Product TypeHuman Prescription Drug
Proprietary NameDICLOFENAC SODIUM DR
Generic NameDiclofenac Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2015-01-16
Marketing CategoryANDA / ANDA
Application NumberANDA074514
Labeler NameNorthwind Pharmaceuticals
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength50 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 Through2019-12-31

Packaging

NDC 51655-308-52

30 TABLET, DELAYED RELEASE in 1 BOTTLE, DISPENSING (51655-308-52)
Marketing Start Date2015-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51655-308-52 [51655030852]

DICLOFENAC SODIUM DR TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA074514
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM50 mg/1

OpenFDA Data

SPL SET ID:bfcd5d3b-30f8-4483-89e2-c67b41b22811
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855906

    • 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 DR" or generic name "Diclofenac Sodium"

    NDCBrand NameGeneric Name
    51655-308DICLOFENAC SODIUM DRDICLOFENAC SODIUM DR
    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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