NDC 75987-010

DUEXIS

Ibuprofen And Famotidine

DUEXIS is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Horizon Therapeutics Usa, Inc.. The primary component is Ibuprofen; Famotidine.

• Product ID: 75987-010_66e942ac-f015-4c57-a99d-4cb7ace0450b
• NDC: 75987-010
• Product Type: Human Prescription Drug
• Proprietary Name: DUEXIS
• Generic Name: Ibuprofen And Famotidine
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-12-05
• Marketing Category: NDA / NDA
• Application Number: NDA022519
• Labeler Name: Horizon Therapeutics USA, Inc.
• Substance Name: IBUPROFEN; FAMOTIDINE
• Active Ingredient Strength: 800 mg/1; mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 75987-010-03

90 TABLET, COATED in 1 BOTTLE (75987-010-03)

• Marketing Start Date: 2011-12-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75987-010-03 [75987001003]

DUEXIS TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA022519
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-12-05

NDC 75987-010-71 [75987001071]

DUEXIS TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA022519
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-11-17
• Marketing End Date: 2015-07-27

NDC 75987-010-72 [75987001072]

DUEXIS TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA022519
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-12-05

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	800 mg/1

OpenFDA Data

• SPL SET ID: 558b9f26-37b2-423b-932d-25a37afe57ec
• Manufacturer:
  • Horizon Pharma Inc.
• UNII:
  • 5QZO15J2Z8
  • WK2XYI10QM
• RxNorm Concept Unique ID - RxCUI:
  • 1100070
  • 1100066
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Histamine H2 Receptor Antagonists [MoA]
• Histamine-2 Receptor Antagonist [EPC]

Medicade Reported Pricing

75987001003 DUEXIS 800-26.6 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "DUEXIS" or generic name "Ibuprofen And Famotidine"

NDC	Brand Name	Generic Name
75987-010	DUEXIS	Ibuprofen and Famotidine
0093-8107	Ibuprofen and famotidine	Ibuprofen and famotidine
63629-8891	Ibuprofen and famotidine	Ibuprofen and famotidine
67877-626	Ibuprofen and famotidine	Ibuprofen and famotidine
69306-266	Ibuprofen and famotidine	Ibuprofen and famotidine
70748-312	Ibuprofen and Famotidine	Ibuprofen and Famotidine