NDC 69399-194

Celecoxib 200 mg

Celecoxib

Celecoxib 200 mg is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sydon Labs Llc. The primary component is Celecoxib.

• Product ID: 69399-194_cf5aa65e-7b73-495d-9115-efd878f259c5
• NDC: 69399-194
• Product Type: Human Prescription Drug
• Proprietary Name: Celecoxib 200 mg
• Generic Name: Celecoxib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204519
• Labeler Name: SYDON LABS 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 69399-194-85

500 CAPSULE in 1 BOTTLE (69399-194-85)

• Marketing Start Date: 2017-03-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69399-194-81 [69399019481]

Celecoxib 200 mg CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204519
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-03-17
• Inactivation Date: 2020-01-31

NDC 69399-194-85 [69399019485]

Celecoxib 200 mg CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204519
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-03-17
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CELECOXIB	200 mg/1

OpenFDA Data

• SPL SET ID: 31b74a7a-50eb-48a5-8285-05bb5df8fbd8
• Manufacturer:
  • SYDON LABS LLC
• UNII:
  • JCX84Q7J1L
• RxNorm Concept Unique ID - RxCUI:
  • 205323
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• UPC Code:
  • 0069399194813
• 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 "Celecoxib 200 mg" or generic name "Celecoxib"

NDC	Brand Name	Generic Name
68788-8969	Celecoxib 200 mg	Celecoxib 200 mg
69399-194	Celecoxib 200 mg	Celecoxib 200 mg
69399-184	Celecoxib 200 mg	Celecoxib 200 mg
53217-206	Celecoxib 200 mg	Celecoxib 200 mg
63187-633	Celecoxib 200 mg	Celecoxib 200 mg
0025-1515	CELEBREX	Celecoxib
0025-1520	CELEBREX	Celecoxib
0025-1525	CELEBREX	Celecoxib
0025-1530	CELEBREX	Celecoxib
0093-7165	Celecoxib	Celecoxib
0093-7166	Celecoxib	Celecoxib
0093-7170	Celecoxib	Celecoxib
0093-7306	Celecoxib	Celecoxib