NDC 61919-075

Diclofenac Sodium D/R

Diclofenac Sodium D/r

Diclofenac Sodium D/R is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Diclofenac Sodium.

Product ID61919-075_3fdaa3f6-dd9d-6a74-e054-00144ff88e88
NDC61919-075
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium D/R
Generic NameDiclofenac Sodium D/r
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA075185
Labeler NameDirect RX
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength75 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 61919-075-30

30 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-075-30)
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-075-60 [61919007560]

Diclofenac Sodium D/R TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-075-20 [61919007520]

Diclofenac Sodium D/R TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-16

NDC 61919-075-90 [61919007590]

Diclofenac Sodium D/R TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-16

NDC 61919-075-30 [61919007530]

Diclofenac Sodium D/R TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

OpenFDA Data

SPL SET ID:2ae3c1e2-f053-4efb-9597-eeac4998d23f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855926
  • 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 D/R" or generic name "Diclofenac Sodium D/r"

    NDCBrand NameGeneric Name
    61919-074Diclofenac Sodium D/RDiclofenac Sodium D/R
    61919-075Diclofenac Sodium D/RDiclofenac Sodium D/R
    61919-060VOLTARENDICLOFENAC SODIUM D/R
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