NDC 61919-046

CELEBREX

Celebrex

CELEBREX is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Celecoxib.

• Product ID: 61919-046_40b7f4e0-35b2-1f4a-e054-00144ff8d46c
• NDC: 61919-046
• Product Type: Human Prescription Drug
• Proprietary Name: CELEBREX
• Generic Name: Celebrex
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA020998
• Labeler Name: Direct Rx
• Substance Name: CELECOXIB
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 61919-046-15

15 CAPSULE in 1 BOTTLE (61919-046-15)

• Marketing Start Date: 2014-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-046-60 [61919004660]

CELEBREX CAPSULE

• Marketing Category: NDA
• Application Number: NDA020998
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-01-01

NDC 61919-046-30 [61919004630]

CELEBREX CAPSULE

• Marketing Category: NDA
• Application Number: NDA020998
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-01-01

NDC 61919-046-90 [61919004690]

CELEBREX CAPSULE

• Marketing Category: NDA
• Application Number: NDA020998
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-01

NDC 61919-046-15 [61919004615]

CELEBREX CAPSULE

• Marketing Category: NDA
• Application Number: NDA020998
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-01

Drug Details

Active Ingredients

Ingredient	Strength
CELECOXIB	200 mg/1

OpenFDA Data

• SPL SET ID: a645dfcd-7343-4c79-af8b-1117e4a5b113
• Manufacturer:
  • Direct Rx
• UNII:
  • JCX84Q7J1L
• RxNorm Concept Unique ID - RxCUI:
  • 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]

NDC Crossover Matching brand name "CELEBREX" or generic name "Celebrex"

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