NDC 69101-400

Fenoprofen Calcium

Fenoprofen Calcium

Fenoprofen Calcium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Burke Therapeutics, Llc. The primary component is Fenoprofen Calcium.

• Product ID: 69101-400_799d4149-5bc6-4843-e053-2a91aa0ade16
• NDC: 69101-400
• Product Type: Human Prescription Drug
• Proprietary Name: Fenoprofen Calcium
• Generic Name: Fenoprofen Calcium
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-03
• Marketing End Date: 2019-11-30
• Marketing Category: NDA / NDA
• Application Number: NDA017604
• Labeler Name: Burke Therapeutics, LLC
• Substance Name: FENOPROFEN CALCIUM
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N

Packaging

NDC 69101-400-01

90 CAPSULE in 1 BOTTLE (69101-400-01)

• Marketing Start Date: 2017-07-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69101-400-01 [69101040001]

Fenoprofen Calcium CAPSULE

• Marketing Category: NDA
• Application Number: NDA017604
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-03
• Marketing End Date: 2019-11-30

Drug Details

Active Ingredients

Ingredient	Strength
FENOPROFEN CALCIUM	400 mg/1

OpenFDA Data

• SPL SET ID: 53af8c84-2ee8-4a88-e054-00144ff8d46c
• Manufacturer:
  • Burke Therapeutics, LLC
• UNII:
  • 0X2CW1QABJ
• RxNorm Concept Unique ID - RxCUI:
  • 858116
• UPC Code:
  • 0369101400011

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "Fenoprofen Calcium" or generic name "Fenoprofen Calcium"

NDC	Brand Name	Generic Name
0276-0501	Fenoprofen Calcium	Fenoprofen Calcium
0276-0502	Fenoprofen Calcium	Fenoprofen Calcium
0276-0503	Fenoprofen Calcium	Fenoprofen Calcium
0378-0471	Fenoprofen Calcium	Fenoprofen Calcium
15014-400	Fenoprofen Calcium	Fenoprofen Calcium
16571-688	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM
42195-100	Fenoprofen Calcium	fenoprofen calcium
42195-471	Fenoprofen Calcium	Fenoprofen Calcium
50090-3572	Fenoprofen Calcium	fenoprofen calcium
53217-169	Fenoprofen Calcium	fenoprofen calcium
54288-131	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM
54288-132	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM
55289-334	Fenoprofen Calcium	Fenoprofen Calcium
63629-8016	Fenoprofen Calcium	fenoprofen calcium
69101-400	Fenoprofen Calcium	Fenoprofen Calcium
69336-124	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM
71335-0307	Fenoprofen Calcium	Fenoprofen Calcium
62250-691	FENOPROFEN	FENOPROFEN CALCIUM
42195-308	Nalfon	fenoprofen calcium
42195-600	Nalfon	fenoprofen calcium
42195-688	NALFON	Fenoprofen Calcium
55700-853	Nalfon	fenoprofen calcium
63187-706	Nalfon	fenoprofen calcium
63629-7515	Nalfon	fenoprofen calcium