NDC 61919-094

DICLOFENAC SODIUM AND MISOPROSTOL

Diclofenac Sodium And Misoprostol

DICLOFENAC SODIUM AND MISOPROSTOL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Diclofenac Sodium; Misoprostol.

Product ID61919-094_44185ca1-5aca-0839-e054-00144ff88e88
NDC61919-094
Product TypeHuman Prescription Drug
Proprietary NameDICLOFENAC SODIUM AND MISOPROSTOL
Generic NameDiclofenac Sodium And Misoprostol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA200158
Labeler NameDIRECT RX
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-094-60

60 TABLET, FILM COATED in 1 BOTTLE (61919-094-60)
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-094-60 [61919009460]

DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200158
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

OpenFDA Data

SPL SET ID:253ee985-e0a0-4674-a114-cfea96304c79
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" 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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