NDC 50090-0450

DIFLUNISAL

Diflunisal

DIFLUNISAL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Diflunisal.

• Product ID: 50090-0450_fea50f9e-e0a5-49d1-8230-717b23c654ef
• NDC: 50090-0450
• Product Type: Human Prescription Drug
• Proprietary Name: DIFLUNISAL
• Generic Name: Diflunisal
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-05-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202845
• Labeler Name: A-S Medication Solutions
• Substance Name: DIFLUNISAL
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50090-0450-2

30 TABLET, FILM COATED in 1 BOTTLE (50090-0450-2)

• Marketing Start Date: 2014-11-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-0450-2 [50090045002]

DIFLUNISAL TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202845
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-11-28
• Marketing End Date: 2019-05-31

NDC 50090-0450-0 [50090045000]

DIFLUNISAL TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202845
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-11-28
• Marketing End Date: 2016-09-01

Drug Details

Active Ingredients

Ingredient	Strength
DIFLUNISAL	500 mg/1

OpenFDA Data

• SPL SET ID: 37729239-cb6d-4773-885d-785e2dd54a4c
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 7C546U4DEN
• RxNorm Concept Unique ID - RxCUI:
  • 197603
• 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]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]

NDC Crossover Matching brand name "DIFLUNISAL" or generic name "Diflunisal"

NDC	Brand Name	Generic Name
0093-0755	Diflunisal	Diflunisal
0093-9222	Diflunisal	Diflunisal
14539-673	diflunisal	diflunisal
23155-673	diflunisal	diflunisal
50090-0450	DIFLUNISAL	DIFLUNISAL
52959-379	DIFLUNISAL	DIFLUNISAL
55289-460	Diflunisal	Diflunisal
55700-559	DIFLUNISAL	DIFLUNISAL
60760-756	Diflunisal	Diflunisal
64980-181	DIFLUNISAL	DIFLUNISAL
68151-0848	Diflunisal	Diflunisal
68382-530	Diflunisal	Diflunisal
70771-1083	Diflunisal	Diflunisal