NDC 61919-608

DICLOFENAC SODIUM E/R

Diclofenac Sodium

DICLOFENAC SODIUM E/R is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Diclofenac Sodium.

Product ID61919-608_85ba4872-19dc-2316-e053-2991aa0a00fc
NDC61919-608
Product TypeHuman Prescription Drug
Proprietary NameDICLOFENAC SODIUM E/R
Generic NameDiclofenac Sodium
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-04-04
Marketing CategoryANDA / ANDA
Application NumberANDA075492
Labeler NameDIRECTRX
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength100 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 Through2020-12-31

Packaging

NDC 61919-608-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-608-30)
Marketing Start Date2019-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-608-60 [61919060860]

DICLOFENAC SODIUM E/R TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075492
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-04

NDC 61919-608-30 [61919060830]

DICLOFENAC SODIUM E/R TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075492
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-04

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM100 mg/1

OpenFDA Data

SPL SET ID:85ba4872-19db-2316-e053-2991aa0a00fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855657

    • 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 E/R" or generic name "Diclofenac Sodium"

    NDCBrand NameGeneric Name
    61919-608DICLOFENAC SODIUM E/RDICLOFENAC SODIUM E/R
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.