NDC 68001-232

Diclofenac Sodium and Misoprostol

Diclofenac Sodium And Misoprostol

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

Product ID68001-232_c18345fd-8079-794b-e053-2a95a90a44fc
NDC68001-232
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium and Misoprostol
Generic NameDiclofenac Sodium And Misoprostol
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-02-26
Marketing CategoryANDA / ANDA
Application NumberANDA201089
Labeler NameBluePoint Laboratories
Substance NameDICLOFENAC SODIUM; MISOPROSTOL
Active Ingredient Strength75 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 Through2022-12-31

Packaging

NDC 68001-232-06

60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-232-06)
Marketing Start Date2014-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68001-232-06 [68001023206]

Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA201089
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-01

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

OpenFDA Data

SPL SET ID:9a22cb4b-e49a-4bd7-b235-47405c302658
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359105
  • 857706
    • UPC Code
  • 0368001232067
  • 0368001231060

    • 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]
    • 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

    68001023206 DICLOFENAC-MISOPROST 75-0.2 TB

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    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
    68001-231Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    68001-232Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    68788-7103Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    68788-9290Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    59762-0029Diclofenac sodium and MisoprostolDiclofenac sodium and Misoprostol
    61919-094DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM AND MISOPROSTOL
    64679-215Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    64679-217Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    65162-436Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    65162-438Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    71335-1183Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    63629-7034Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    63629-4970Diclofenac Sodium and MisoprostolDiclofenac Sodium and Misoprostol
    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
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