NDC 55289-406

ARTHROTEC

Diclofenac Sodium And Misoprostol

ARTHROTEC is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Diclofenac Sodium; Misoprostol.

Product ID55289-406_7c1f7133-88c4-afe7-e053-2991aa0a3f0c
NDC55289-406
Product TypeHuman Prescription Drug
Proprietary NameARTHROTEC
Generic NameDiclofenac Sodium And Misoprostol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1997-12-24
Marketing CategoryNDA / NDA
Application NumberNDA020607
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameDICLOFENAC SODIUM; MISOPROSTOL
Active Ingredient Strength50 mg/1; ug/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 55289-406-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-406-30)
Marketing Start Date2011-07-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-406-15 [55289040615]

ARTHROTEC TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020607
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-28
Marketing End Date2019-09-12

NDC 55289-406-30 [55289040630]

ARTHROTEC TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020607
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-28
Marketing End Date2019-09-12

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM50 mg/1

OpenFDA Data

SPL SET ID:a388be87-4a3e-4501-8895-46101fdda1f3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359107
  • 857706
    • UPC Code
  • 0355289406150

    • 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]

    NDC Crossover Matching brand name "ARTHROTEC" or generic name "Diclofenac Sodium And Misoprostol"

    NDCBrand NameGeneric Name
    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

    Trademark Results [ARTHROTEC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ARTHROTEC
    ARTHROTEC
    78371291 3008611 Live/Registered
    G. D. SEARLE LLC
    2004-02-20
    ARTHROTEC
    ARTHROTEC
    74005480 1655099 Dead/Cancelled
    G. D. SEARLE & CO.
    1989-11-27
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.