NDC 75834-265

Diclofenac Sodium Misoprostol

Diclofenac Sodium And Misoprostol

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

Product ID75834-265_66971c8a-2e89-4dbc-8caf-d37ef18913d3
NDC75834-265
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium Misoprostol
Generic NameDiclofenac Sodium And Misoprostol
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2021-07-15
Marketing CategoryANDA /
Application NumberANDA205143
Labeler NameNivagen Pharmaceuticals, Inc.
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 75834-265-60

60 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-265-60)
Marketing Start Date2021-07-15
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Diclofenac Sodium Misoprostol" 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
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