NDC 71335-0357

Diclofenac Sodium Delayed Release

Diclofenac Sodium

Diclofenac Sodium Delayed Release is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Diclofenac Sodium.

Product ID71335-0357_0f4fb7b7-e7e5-4a07-a3a6-1061aa062e59
NDC71335-0357
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium Delayed Release
Generic NameDiclofenac Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date1998-11-13
Marketing CategoryANDA / ANDA
Application NumberANDA075185
Labeler NameBryant Ranch Prepack
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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71335-0357-0

40 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0357-0)
Marketing Start Date2012-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0357-5 [71335035705]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-06

NDC 71335-0357-0 [71335035700]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-06

NDC 71335-0357-3 [71335035703]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-06

NDC 71335-0357-2 [71335035702]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-06

NDC 71335-0357-4 [71335035704]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-06

NDC 71335-0357-7 [71335035707]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-06

NDC 71335-0357-8 [71335035708]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-06

NDC 71335-0357-6 [71335035706]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-06

NDC 71335-0357-9 [71335035709]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-06

NDC 71335-0357-1 [71335035701]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-06

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

OpenFDA Data

SPL SET ID:ae0add8e-3a8a-4c5d-af3b-907f64211fef
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 Delayed Release" or generic name "Diclofenac Sodium"

    NDCBrand NameGeneric Name
    68071-3184Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    68071-4231Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    68071-4117Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    68788-8952Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    68788-9806Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    70518-0627Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    70518-0756Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    70518-1104Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    70934-165Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    70934-122Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    70934-157Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    71335-0357Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    71335-0481Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    10544-188Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    10544-189Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    42254-059Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    43063-694Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    43063-693Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    50090-0542Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    50090-0543Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    50090-0545Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    50436-1022Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    53002-5360Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    53002-5370Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    60760-154Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    61145-101Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    61442-102Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    60760-153Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    61442-101Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    61442-103Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    61145-102Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    63187-222Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    63629-1012Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    63629-1011Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    63629-1534Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    63629-7654Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    63629-7655Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    68071-4934Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    0440-6396Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
    45865-999Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed 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
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