NDC 63629-4970

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 Bryant Ranch Prepack. The primary component is Diclofenac Sodium; Misoprostol.

Product ID63629-4970_6dfe5eaa-959a-49ca-9a17-366ed52c3b8e
NDC63629-4970
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium and Misoprostol
Generic NameDiclofenac Sodium And Misoprostol
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2012-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA201089
Labeler NameBryant Ranch Prepack
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 FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63629-4970-1

20 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4970-1)
Marketing Start Date2013-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4970-2 [63629497002]

Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA201089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-09
Marketing End Date2018-01-30

NDC 63629-4970-1 [63629497001]

Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA201089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-09
Marketing End Date2018-01-30

NDC 63629-4970-3 [63629497003]

Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA201089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-09
Marketing End Date2018-01-30

NDC 63629-4970-4 [63629497004]

Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA201089
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-09
Marketing End Date2018-01-30

Drug Details

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.