NDC 69339-124

Diclofenac Sodium and Misoprostol Delayed-Release

Diclofenac Sodium And Misoprostol

Diclofenac Sodium and Misoprostol Delayed-Release is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Dash Pharmaceuticals Llc. The primary component is Diclofenac Sodium; Misoprostol.

Product ID69339-124_4f699505-4205-4430-8959-8e929b986112
NDC69339-124
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium and Misoprostol Delayed-Release
Generic NameDiclofenac Sodium And Misoprostol
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2015-01-23
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA200540
Labeler NameDash Pharmaceuticals LLC
Substance NameDICLOFENAC SODIUM; MISOPROSTOL
Active Ingredient Strength75 mg/1; mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC Exclude FlagN

Packaging

NDC 69339-124-06

60 TABLET, DELAYED RELEASE in 1 BOTTLE (69339-124-06)
Marketing Start Date2016-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69339-124-06 [69339012406]

Diclofenac Sodium and Misoprostol Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA200540
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-15
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

OpenFDA Data

SPL SET ID:fb7801a4-8380-4a72-a925-79bbe080b659
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359105
  • 857706
    • UPC Code
  • 0369339123065
  • 0369339124062
  • 0369339123096

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Decreased Prostaglandin Production [PE]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Prostaglandin E1 Analog [EPC]
    • Prostaglandins E
    • Synthetic [CS]

    Medicade Reported Pricing

    69339012406 DICLOFENAC-MISOPROST 75-0.2 TB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Diclofenac Sodium and Misoprostol Delayed-Release" or generic name "Diclofenac Sodium And Misoprostol"

    NDCBrand NameGeneric Name
    69339-124Diclofenac Sodium and Misoprostol Delayed-ReleaseDiclofenac Sodium and Misoprostol Delayed-Release
    69339-123Diclofenac Sodium and Misoprostol Delayed-ReleaseDiclofenac Sodium and Misoprostol Delayed-Release
    0025-1411ARTHROTECdiclofenac sodium and misoprostol
    0025-1421ARTHROTECdiclofenac sodium and misoprostol
    21695-425ARTHROTECdiclofenac sodium and misoprostol
    49999-987ARTHROTECdiclofenac sodium and misoprostol
    55289-406ARTHROTECdiclofenac sodium and misoprostol
    0591-0397Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    0591-0398Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    10544-949Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    10544-955Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    42291-232Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    42291-233Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    42367-110Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    42367-111Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    50090-4618Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    55648-215Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    55648-217Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    59762-0028Diclofenac sodium and MisoprostolDiclofenac sodium and Misoprostol
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