NDC 42367-111

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 Eagle Pharmaceuticals, Inc.. The primary component is Diclofenac Sodium; Misoprostol.

Product ID42367-111_a9cea5dd-d282-4ba2-ac44-d8b01eceffb1
NDC42367-111
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 Date2014-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA200540
Labeler NameEagle Pharmaceuticals, Inc.
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
Listing Certified Through2019-12-31

Packaging

NDC 42367-111-06

60 TABLET, DELAYED RELEASE in 1 BOTTLE (42367-111-06)
Marketing Start Date2014-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42367-111-06 [42367011106]

Diclofenac Sodium and Misoprostol Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA200540
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

OpenFDA Data

SPL SET ID:4616cae3-c91b-477c-94b0-d3f4468a59d9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359105
  • 857706
    • UPC Code
  • 0342367110092
  • 0342367111068
  • 0342367110061

    • 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

    42367011106 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.