NDC 45865-918

Flurbiprofen

Flurbiprofen

Flurbiprofen is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Flurbiprofen.

• Product ID: 45865-918_7df1195c-d1db-3139-e053-2991aa0adda2
• NDC: 45865-918
• Product Type: Human Prescription Drug
• Proprietary Name: Flurbiprofen
• Generic Name: Flurbiprofen
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1995-06-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074431
• Labeler Name: medsource pharmaceuticals
• Substance Name: FLURBIPROFEN
• Active Ingredient Strength: 100 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 45865-918-30

30 TABLET, FILM COATED in 1 BOTTLE (45865-918-30)

• Marketing Start Date: 2018-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45865-918-30 [45865091830]

Flurbiprofen TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA074431
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-01

NDC 45865-918-90 [45865091890]

Flurbiprofen TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA074431
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-01

NDC 45865-918-60 [45865091860]

Flurbiprofen TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA074431
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-01

Drug Details

Active Ingredients

Ingredient	Strength
FLURBIPROFEN	100 mg/1

OpenFDA Data

• SPL SET ID: 7df104c9-edb9-6aaf-e053-2a91aa0aefad
• Manufacturer:
  • medsource pharmaceuticals
• UNII:
  • 5GRO578KLP
• RxNorm Concept Unique ID - RxCUI:
  • 197724
• 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 "Flurbiprofen" or generic name "Flurbiprofen"

NDC	Brand Name	Generic Name
0093-0711	Flurbiprofen	Flurbiprofen
0378-0076	Flurbiprofen	flurbiprofen
0378-0093	Flurbiprofen	flurbiprofen
43063-992	Flurbiprofen	Flurbiprofen
45865-918	Flurbiprofen	Flurbiprofen
49999-311	Flurbiprofen	Flurbiprofen
50090-0509	Flurbiprofen	Flurbiprofen
55289-561	Flurbiprofen	flurbiprofen
63629-8338	Flurbiprofen	Flurbiprofen
63629-8808	Flurbiprofen	Flurbiprofen
68071-2480	Flurbiprofen	Flurbiprofen
68071-4436	Flurbiprofen	Flurbiprofen
68788-7341	Flurbiprofen	Flurbiprofen
69642-1300	Antiphlamine Pain Relieving	Flurbiprofen