NDC 0378-0076

Flurbiprofen

Flurbiprofen

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

• Product ID: 0378-0076_81970638-c9fa-4010-9908-3cca07fd92e5
• NDC: 0378-0076
• Product Type: Human Prescription Drug
• Proprietary Name: Flurbiprofen
• Generic Name: Flurbiprofen
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1994-06-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074358
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: FLURBIPROFEN
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0378-0076-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0076-01)

• Marketing Start Date: 1994-06-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0076-01 [00378007601]

Flurbiprofen TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA074358
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-06-20
• Marketing End Date: 2020-08-31

Drug Details

Active Ingredients

Ingredient	Strength
FLURBIPROFEN	50 mg/1

OpenFDA Data

• SPL SET ID: 86b915c9-9c00-46c2-8dd9-3e15a6b42323
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 5GRO578KLP
• RxNorm Concept Unique ID - RxCUI:
  • 197724
  • 197725
• 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]

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