NDC 21695-040

Diclofenac Sodium Extended-Release

Diclofenac Sodium

Diclofenac Sodium Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Diclofenac Sodium.

Product ID21695-040_51b4f63e-03fd-40f4-804b-39fd80842fd6
NDC21695-040
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium Extended-Release
Generic NameDiclofenac Sodium
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2002-01-07
Marketing CategoryANDA / ANDA
Application NumberANDA075910
Labeler NameRebel Distributors Corp.
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-040-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-040-30)
Marketing Start Date2002-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-040-90 [21695004090]

Diclofenac Sodium Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075910
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-07
Inactivation Date2019-09-24

NDC 21695-040-60 [21695004060]

Diclofenac Sodium Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075910
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-07
Inactivation Date2019-09-24

NDC 21695-040-30 [21695004030]

Diclofenac Sodium Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075910
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-07
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM100 mg/1

OpenFDA Data

SPL SET ID:688fa1d0-6e17-4191-8618-8f62bc7765d3
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 Extended-Release" or generic name "Diclofenac Sodium"

    NDCBrand NameGeneric Name
    21695-040Diclofenac Sodium Extended-ReleaseDiclofenac Sodium Extended-Release
    45865-364Diclofenac Sodium Extended-ReleaseDiclofenac Sodium Extended-Release
    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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