NDC 63539-016

XELJANZ

Tofacitinib

XELJANZ is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by U.s. Pharmaceuticals. The primary component is Tofacitinib Citrate.

• Product ID: 63539-016_11ae0c37-f8b9-44bf-b4a7-aef76dd348e3
• NDC: 63539-016
• Product Type: Human Prescription Drug
• Proprietary Name: XELJANZ
• Generic Name: Tofacitinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-02
• Marketing Category: NDA / NDA
• Application Number: NDA203214
• Labeler Name: U.S. Pharmaceuticals
• Substance Name: TOFACITINIB CITRATE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Janus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63539-016-02

60 TABLET, FILM COATED in 1 BOTTLE (63539-016-02)

• Marketing Start Date: 2018-07-02
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 63539-016-02 [63539001602]

XELJANZ TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA203214
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-02

Drug Details

Active Ingredients

Ingredient	Strength
TOFACITINIB CITRATE	10 mg/1

OpenFDA Data

• SPL SET ID: 68e3d6b2-7838-4d2d-a417-09d919b43e13
• Manufacturer:
  • U.S. Pharmaceuticals
• UNII:
  • O1FF4DIV0D
• RxNorm Concept Unique ID - RxCUI:
  • 1357547
  • 1357541
  • 1741049
  • 2048566
  • 2048568
  • 1741046

Pharmacological Class

• Janus Kinase Inhibitor [EPC]
• Janus Kinase Inhibitors [MoA]

NDC Crossover Matching brand name "XELJANZ" or generic name "Tofacitinib"

NDC	Brand Name	Generic Name
0069-0501	XELJANZ	tofacitinib
0069-0502	XELJANZ	tofacitinib
0069-1001	XELJANZ	tofacitinib
0069-1002	XELJANZ	tofacitinib
63539-012	XELJANZ	XELJANZ
63539-016	XELJANZ	XELJANZ
0069-1029	XELJANZ	XELJANZ