NDC 71335-1183

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 ID71335-1183_cfe230e5-8ace-459f-8889-ef4b1ecba0c8
NDC71335-1183
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium and Misoprostol
Generic NameDiclofenac Sodium And Misoprostol
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA203995
Labeler NameBryant Ranch Prepack
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 Through2020-12-31

Packaging

NDC 71335-1183-1

20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-1)
Marketing Start Date2019-04-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1183-2 [71335118302]

Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-16

NDC 71335-1183-3 [71335118303]

Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-16

NDC 71335-1183-1 [71335118301]

Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-16

NDC 71335-1183-5 [71335118305]

Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-16

NDC 71335-1183-4 [71335118304]

Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-16

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

OpenFDA Data

SPL SET ID:d6671b66-00ad-4949-b51a-36e1130b1cb5
Manufacturer
UNII

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]

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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