NDC 53002-5360

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 Rpk Pharmaceuticals, Inc.. The primary component is Diclofenac Sodium.

Product ID53002-5360_c6cf5e51-054e-4a7b-a40d-c4d0e5f19546
NDC53002-5360
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 NameRPK Pharmaceuticals, Inc.
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 Through2019-12-31

Packaging

NDC 53002-5360-1

10 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5360-1)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-5360-2 [53002536002]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-5360-1 [53002536001]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-5360-5 [53002536005]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-5360-3 [53002536003]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

OpenFDA Data

SPL SET ID:89ccfc76-245f-4604-bc1d-9115c657c340
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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