NDC 63539-501

XELJANZ XR

Tofacitinib

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

• Product ID: 63539-501_11ae0c37-f8b9-44bf-b4a7-aef76dd348e3
• NDC: 63539-501
• Product Type: Human Prescription Drug
• Proprietary Name: XELJANZ XR
• Generic Name: Tofacitinib
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-07
• Marketing Category: NDA / NDA
• Application Number: NDA208246
• Labeler Name: U.S. Pharmaceuticals
• Substance Name: TOFACITINIB CITRATE
• Active Ingredient Strength: 11 mg/1
• Pharm Classes: Janus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63539-501-14

14 TABLET, EXTENDED RELEASE in 1 BOTTLE (63539-501-14)

• Marketing Start Date: 2016-03-07
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 63539-501-14 [63539050114]

XELJANZ XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208246
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-07

NDC 63539-501-30 [63539050130]

XELJANZ XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208246
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-07

Drug Details

Active Ingredients

Ingredient	Strength
TOFACITINIB CITRATE	11 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 XR" or generic name "Tofacitinib"

NDC	Brand Name	Generic Name
63539-501	XELJANZ XR	XELJANZ XR
63539-502	XELJANZ XR	XELJANZ XR
0069-0501	XELJANZ	tofacitinib
0069-0502	XELJANZ	tofacitinib
0069-1001	XELJANZ	tofacitinib
0069-1002	XELJANZ	tofacitinib