NDC 63539-502

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: 63539-502_11ae0c37-f8b9-44bf-b4a7-aef76dd348e3
• NDC: 63539-502
• Product Type: Human Prescription Drug
• Proprietary Name: XELJANZ XR
• Generic Name: Tofacitinib
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2020-01-21
• Marketing Category: NDA / NDA
• Application Number: NDA208246
• Labeler Name: U.S. Pharmaceuticals
• Substance Name: TOFACITINIB CITRATE
• Active Ingredient Strength: 22 mg/1
• Pharm Classes: Janus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63539-502-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63539-502-30)

• Marketing Start Date: 2020-01-21
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 63539-502-30 [63539050230]

XELJANZ XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208246
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-21

Drug Details

Active Ingredients

Ingredient	Strength
TOFACITINIB CITRATE	22 mg/1

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