NDC 67544-204

CELEBREX

Celecoxib

CELEBREX is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Celecoxib.

• Product ID: 67544-204_a427cdfd-7e1f-4f7c-ba6a-167e56d9d340
• NDC: 67544-204
• Product Type: Human Prescription Drug
• Proprietary Name: CELEBREX
• Generic Name: Celecoxib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1998-10-02
• Marketing Category: NDA / NDA
• Application Number: NDA020998
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: CELECOXIB
• Active Ingredient Strength: 200 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 67544-204-30

30 CAPSULE in 1 BOTTLE, PLASTIC (67544-204-30)

• Marketing Start Date: 1998-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67544-204-30 [67544020430]

CELEBREX CAPSULE

• Marketing Category: NDA
• Application Number: NDA020998
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-10-02
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CELECOXIB	200 mg/1

OpenFDA Data

• SPL SET ID: 05cf80f2-12a0-46b0-bcb7-1c982ed7bd3e
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • JCX84Q7J1L
• RxNorm Concept Unique ID - RxCUI:
  • 213469
  • 205323
• 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 "CELEBREX" or generic name "Celecoxib"

NDC	Brand Name	Generic Name
0025-1515	CELEBREX	Celecoxib
0025-1520	CELEBREX	Celecoxib
0025-1525	CELEBREX	Celecoxib
0025-1530	CELEBREX	Celecoxib
68387-552	CELEBREX	CELEBREX
68788-0768	CELEBREX	CELEBREX
21695-023	CELEBREX	CELEBREX
21695-022	CELEBREX	CELEBREX
33261-019	CELEBREX	CELEBREX
49999-383	CELEBREX	CELEBREX
52959-540	CELEBREX	CELEBREX
52959-539	CELEBREX	CELEBREX
55154-3621	CELEBREX	CELEBREX
55154-3622	CELEBREX	CELEBREX
55289-451	CELEBREX	CELEBREX
55154-3625	CELEBREX	CELEBREX
55289-475	CELEBREX	CELEBREX
61919-046	CELEBREX	CELEBREX
63187-079	CELEBREX	CELEBREX
63629-6368	CELEBREX	CELEBREX
63629-3021	CELEBREX	CELEBREX
66336-940	CELEBREX	CELEBREX
67544-204	CELEBREX	CELEBREX
80425-0096	Celebrex	Celebrex
80425-0038	Celebrex	Celebrex
80425-0040	Celebrex	Celebrex
80425-0037	Celebrex	Celebrex
80425-0039	Celebrex	Celebrex
0093-7165	Celecoxib	Celecoxib
0093-7166	Celecoxib	Celecoxib
0093-7170	Celecoxib	Celecoxib
0093-7306	Celecoxib	Celecoxib