NDC 80425-0210

Diclofenac Sodium ER

Diclofenac Sodium

Diclofenac Sodium ER is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Advanced Rx Pharmacy Of Tennessee, Llc. The primary component is Diclofenac Sodium.

Product ID80425-0210_f059a524-5d5c-5f0f-e053-2995a90a2c09
NDC80425-0210
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium ER
Generic NameDiclofenac Sodium
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-11-04
Marketing CategoryANDA /
Application NumberANDA075492
Labeler NameAdvanced Rx Pharmacy of Tennessee, LLC
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength100 mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Drug Details

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

NDCBrand NameGeneric Name
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.