NDC 10544-955

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 Blenheim Pharmacal, Inc.. The primary component is Diclofenac Sodium; Misoprostol.

Product ID10544-955_3282624b-6a8a-16b4-e054-00144ff8d46c
NDC10544-955
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 NameBlenheim Pharmacal, 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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10544-955-14

14 TABLET, DELAYED RELEASE in 1 BOTTLE (10544-955-14)
Marketing Start Date2016-02-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-955-14 [10544095514]

Diclofenac Sodium and Misoprostol Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA200540
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

OpenFDA Data

SPL SET ID:31dd8572-989c-1416-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359105

    • 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 "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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